Research

Determination of following pharmacopoeial standards would be performed for three formulations namely Hutabhugadi curna, Sitopaladi curna and Caturjata Curna as per the procedures mentioned in Ayurvedic Pharmacopoeia of India and quality Control Methods of Medicinal Plant Materials by WHO.
1 Microscopic Identification
2 Foreign Matter
3 Total Ash
4 Acid-Insoluble Ash
5 Alcohol-Soluble Extractive
6 Water-Soluble Extractive
7 Ether-Soluble Extractive (Fixed Oil Content)
8 Moisture Content (Loss on Drying)
9 Volatile Oil in Drugs
10 Thin Layer Chromatography (TLC)
11 HPTLC/HPLC fingerprinting of ingredients/ finished products:
12 Microbial Limit Tests
13 Stability studies
Physical and chemical tests like pH value, solubility in water, saponification value, iodine value, acid value, peroxide value, unsaponifiable matter, etc will be carried out as per the requirement.
Chemical Tests and Assays like estimation of total phenolics, tannins, sugars, reducing sugars, total sugars, non-reducing sugars, calcium, sodium and potassium by Flame Photometry, etc would be carried out as per requirement.
The studies would be performed by suitably trained and qualified staff employing properly calibrated and standardized equipment of adequate size and capacity. Studies would be done as per written protocols with modifications (if any) verifiable retrospectively. Standard operating procedures (SOPs) would be followed for all managerial and laboratory tasks related to these studies. All documents belonging to each study, including its approved protocol, raw data, draft report, final report, and histology slides and paraffin tissue blocks would be preserved as per the statutory requirement (five years).
1. Microscopic identification: Microscopic identification of the botanical ingredients is a standard for statutory purposes in several solid and semi-solid compound formulations. Microscopic identification tests are confined to those formulations where the botanical ingredients are not more than ten.

2. Foreign Matter: The sample shall be free from visible signs of mold growth, sliminess, stones, rodent excreta, insects or any other noxious foreign matter when examined as given below. Take a representative portion from a large container, or remove the entire contents of the packing if 100 g or less, and spread in a thin layer in a suitable dish or tray. Examine in daylight with unaided eye. Transfer suspected particles, if any, to a petri dish, and examine with 10x lens in daylight.

3. Determination of Total Ash:
Incinerate about 2 to 3 g accurately weighed, of the ground drug in a tared platinum or silica dish at a temperature not exceeding 4500 until free from carbon, cool and weigh. If a carbon free ash cannot be obtained in this way, exhaust the charred mass with hot water, collect the residue on an ashless filter paper, incinerate the residue and filter paper, add the filtrate, evaporate to dryness, and ignite at a temperature not exceeding 4500. Calculate the percentage of ash with reference to the air-dried drug.

4. Determination of Acid-Insoluble Ash:
To the crucible containing total ash, add 25 ml of dilute hydrochloric acid. Collect the insoluble matter on an ashless filter paper (Whatman 41) and wash with hot water until the filtrate is neutral. Transfer the filter paper containing the insoluble matter to the original crucible, dry on a hot-plate and ignite to constant weight. Allow the residue to cool in a suitable desiccator for 30 minutes and weigh without delay. Calculate the content of acid-insoluble ash with reference to the air-dried drug.

5. Determination of Alcohol Soluble Extractive:
Macerate 5 g of the air dried drug, coarsely powdered, with 100 ml of alcohol the specified strength in a closed flask for twenty-four hours, shaking frequently during six hours and allowing to stand for eighteen hours. Filter rapidly, taking precautions against loss of solvent, evaporate 25 ml of the filtrate to dryness in a tared flat bottomed shallow dish, and dry at 1050, to constant weight and weight. Calculate the percentage of alcohol-soluble extractive with reference to the air-dried drug.
6. Determination of Water Soluble Extractive:
Proceed as directed for the determination of alcohol-soluble extractive, using chloroform-water instead of ethanol.
7. Determination of Ether Soluble Extractive (Fixed Oil Content):
Transfer a suitably weighed quantity (depending on the fixed oil content) of the air dried, crushed drug to an extraction thimble, extract with solvent ether (or petroleum ether, b.p. 400 to 600) in a continuous extraction apparatus (Soxhlet extractor) for 6 hours. Filter the extract quantitatively into a tared evaporating dish and evaporate off the solvent on a water bath. Dry the residue at 1050 to constant weight. Calculate the percentage of ether-soluble extractive with reference to the air-dried drug.
8. Determination of Moisture Content (Loss on Drying):
Procedure set forth here determines the amount of volatile matter (i.e., water drying off from the drug). For substances appearing to contain water as the only volatile constituent, the procedure given below, is appropriately used. Place about 10 g of drug (without preliminary drying) after accurately weighing (accurately weighed to within 0.01 g) it in a tared evaporating dish. For example, for unground or unpowderd drug, prepare about 10 g of the sample by cutting shredding so that the parts are about 3 mm in thickness. Seeds and fruits, smaller than 3 mm should be cracked. Avoid the use of high speed mills in preparing the samples, and exercise care that no appreciable amount of moisture is lost during preparation and that the portion taken is representative of the official sample. After placing the above said amount of the drug in the tared evaporating dish, dry at 1050 for 5 hours, and weigh. Continue the drying and weighing at one hour interval until difference between two successive weighing corresponds to not more than 0.25 per cent. Constant weight is reached when two consecutive weighing after drying for 30 minutes and cooling for 30 minutes in a desiccator, show not more than 0.01 g difference.
9. Determination of Volatile Oil in Drugs
The determination of volatile oil in a drug is made by distilling the drug with a mixture of water and glycerin, collecting the distillate in a graduated tube in which the aqueous portion of the distillate is automatically separated and returned to the distilling flask, and measuring the volume of the oil. The content of the volatile oil is expressed as a percentage v/w. The apparatus consists of the following parts . The clevenger’s apparatus described below is recommended but any similar apparatus may be used provided that it permits complete distillation of the volatile oil. All glass parts of the apparatus should be made of good quality resistance glass.
10. Thin-Layer Chromatography (TLC):
Thin-layer chromatography is a technique in which a solute undergoes distribution between two phases, stationary phase acting through adsorption and a mobile phase in the form of a liquid. The adsorbent is a relatively thin, uniform layer of dry finely powdered material applied to a glass, plastic or metal sheet or plate. Precoated plates are most commonly used. Separation may also be achieved on the basis of partition or a combination of partition and adsorption, depending on the particular type of support, its preparation and its use with different solvent. Identification can be effected by observation of spots of identical Rf value and about equal magnitude obtained, respectively, with an unknown and a reference sample chromatographed on the same plate. A visual comparison of the size and intensity of the spots usually serves for semi-quantitative estimation.
11. HPTLC/HPLC fingerprinting of ingredients/ finished products:
Relevant extract would be analysed for its fingerprint profile for the standardization purpose. As the instrument facility is not available, the work would be carried out by outsourcing.
12. Microbial Limit Tests:
The following tests are designed for the estimation of the number of viable aerobic micro-organisms present and for detecting the presence of designated microbial species in pharmaceutical substances. The term ‘growth’ is used to designate the presence and presumed proliferation of viable micro-organisms.
Permissible limits for microbial contamination
1. Staphylococcus aureus/g. Absent
2. Salmonella sp./g . Absent
3. Pseudomonas aeruginosa/g Absent
4. Escherichia coli Absent
5. Total microbial plate count (TPC) 105/g*
6. Total Yeast & Mould 103/g
*For topical use, the limit shall be 107/g.
13. Stability study:
Stability of the formulations would be studied as per the standardized methodology

BASIC INSTRUMENT REQUIRED FOR RESEARCH CENTER – SDM UDUPI

Microscopy facility
1. Dissection microscope
2. Olympus Binocular microscope
3. Zeiss Stereo microscope with digital camera attachment
4. Zeiss Trinocular Microscope with digital camera attachment (AXIO
5. Inverted Microscope

II. Pharmacognosy laboratory
1. Hot air oven
2. Leaf area meter
3. Desiccators
4. Analytical balance
5. High precision single pan balance
6. Herbarium cabinets of different size
7. Sieve Shaker with various types of sieves
8. Moisture analyzer
9. Refrigerator
10. Electronic balance
11. Digital Compact camera
12. Rotaevaporator IKA
13. Tray drier
14. Muffle furnace

III. Pharmaceutical Chemistry lab 1 (Chromatography lab)
1. Shimadzu High Pressure Liquid Chromatography (HPLC)
2. CAMAG High Performance TLC Systems (HPTLC)
3. UV-Visible double beam spectrophotometer
4. Thin layer chromatography set
5. Paper Chromatography cabinet
6. Electronic analytical and precision balance

7. High pressure seamless Nitrogen gas cylinder
8. Abbe’s Refractometer
9. Melting point apparatus
10. Desiccators
11. Hair drier
12. Hot air oven
13. Percolators of different sizes ( 1 to 15 liters capacity)
14. Fume hood
15. Single pan balance
16. Mono quartz distillation unit
17. Heating mantle
18. Bulk density apparatus
19. Water bath
20. UV cabinet
21. Constant temperature bath
22. Extraction mantle
23. Chemical balance
24. Digital colorimeter
25. Desiccators
26. Flame photometer
27. Deionizer plant
28. Cyclomixer
29. Diffusion cell apparatus
30. Oil free portable vacuum cum pressure pump
31. Vacuum pump
32. All purpose pharmacy instrument and equipment assembly
33. Tablet disintegration test machine
34. Tablet hardness tester
35. Tablet dissolution testing apparatus

 

Ethical and Rights Concerns in Health

Cases

  • Discrimination of women- health centers dilapidated for the delivery- no equipment and midwife – death of the child (Kabul, Afghanistan)
  • HIV Aids Patient- ill- health centers- heath staff not treating (Sub-Sahara Africa)
  • Research medical team- insufficient budget- cannot act on prevailing problems (West Africa)
  • Elected government- medical facilities on cities- no in countryside (India)

Importance of Issues

  • Complementary between good ethical and human rights practice – lead to the good health outcomes.
  • Human rights- Access to health services and health information- but poor and disenfranchised suffer from gap.
  • Highly stigmatize scenario- cannot stop progression of disease and stop untill and unless health worker afraid to work (leprosy, tb, aids)
  • New emerging disease (human right vs eradication of disease)
  • Research and Human subjects – research conducted with poor people
  • Health investments and fair (Which population and disease group)

 

Foundations

  • 1948- Universal Declaration for Human Rights (UDHR)- basis for treaties and documents
    • Customary international law-unwritten law
  • 1966- ICESCR & ICCPR
  • ICESCR (Interantion Covenant on Economic, Social and Cultural Rights)
  • ICCPR (International Covenant on Civil and Political Rights)

 

Documents make the obligations on government to respect, protect and fulfill the rights they state;

            that is , to refrain from violating people rights, to prevent others from violating them, and to actively promote the realization of peoples rights.

Challenges

  • Poor countries
  • MDG not taking human rights explicitly into account frequently (SDG ?)
  • No clear definitions and agreed indicators for measuring progression

 

 Achievements

  • Countries includes right to health and health care in their constitution.
  • Successful results (Brazil, Venezula, South Africa)

 

Vulnerable group: Woman and Child

  • 1979- UNGA – Conventional on the Elimination of all Forms of Discrimination Against Women – elimination of discriminary practice and reproduction rights
  • 1989 – CRC (Convention on the rights of the child)- below the age of 18 years free of discriminating, to health, to education.
  • Issues of Health

 

Working together to improve Global health

Vignettes

  • qEradication of Polio 2004 challenges
  • qTB eradication challenges
  • qVaccination accessibity to all the nations
  • qLess economic investments in finding newer drug

Cooperation WHY

  • qNutrition vs HIV / AIDS- HIV/AIDS is focused by all countries to combat
  • qAntimalarial regimen-  knowledge of drug regimen more effective- standard protocol-  WHO promulgate strategy
  • qGlobal public goods – production and sharing
  • qPollution
  • qCommunicable disease
  • qCollaborative surveillance – SARC (2003)
  • qAssist in financial health effort
  • qSelf interest
  • qNative peoples health secure

International guidelines for different types of research

Randomised trials CONSORT Extensions
Observational studies STROBE Extensions
Systematic reviews PRISMA Extensions
Case reports CARE Extensions
Qualitative research SRQR COREQ
Diagnostic / prognostic studies STARD TRIPOD
Quality improvement studies SQUIRE
Economic evaluations CHEERS
Animal pre-clinical studies ARRIVE
Study protocols SPIRIT PRISMA-P
Clinical practice guidelines AGREE RIGHT

Basic Concept of Research Proposal

  1. Project Title
  • Should be brief but specific
  • Not more than 15 words
  1. Proposal Summary
  • Should not exceed more than half a page (A4) double space No.10 font size.
  • Should describe briefly the main objective, methodology, data management process, outcome, justification etc.
  • Not more than three hundred words
  • Underline the key words up to 4 for computer search or library search in future
  1. Proposal Introduction
  • Should specify the problem being investigated and establish why it is important.
  • Some references to the literature can be made.
  1. Statement of Problem
  • Should be stated clearly, concisely and definitely.
  • Should express a relation between two or more variables.
  • Should be expressed in an orderly system of relationships.
  • Must indicate what was done in the study (i.e what was tested, determined, effected, compared, analyzed, evaluated etc. )
  1. Literature Review
  • Should organize the note according to which aspect of the problem researcher address.
  • Should write a discussion in your own words using all the relevant information.
  1. Rationale /Justification
  • Should have to elaborate the purpose statement, and present examples of how the problem has manifested itself in society.
  • Use the literature to help show why the study is needed, to explain why it is significant, or to justify its content.
  1. Research Question
  • What is in the study population to be explored is said to be research question.
  • Don’t try to develop too many research questions one or two will be enough.
  1. Research Hypothesis
  • Should state a relationship between at least two variables.
  • Should not be too vague or general.
  • Should be specific and simple.
  • Should be properly expressed.
  • Should be stated in present tense.
  • Should express its capability of being refuted; the prediction can be evaluated in terms of “Yes it occurred” or “ no, it did not occurred”.
  • Should be in easily tested form.
  1. Research Objectives
  • Should be closely related to the statement of the problem and should cover the different aspects of the problems and its contributing factors in a coherent way and in logical sequence.
  • Should be short, precise and comprehensive.
  • Should be target oriented with outcomes.
  • Should be realistic and measurable for evaluation.
  • Should be phrased in operational specifying exactly
  1. i) what you plan to do    ii) to whom it will be done

iii) when it will be done  iv) for what purpose.

  • Should have action verbs that are specific enough to be evaluated ( e.g. to determine, to identify, to verify, to calculate, to describe, and to establish etc )

9.1 General Objective

  • Should be stated in one or two sentences out lining the broad prospective of the study in general terms.

9.2 Specific Objectives

  • Should be stated in number of ways preferably in sequential order or logically connected parts.
  • Should reflect towards the general objectives.
  1. Research Methodology

10.1 Site selection: Where ?,  Include the justification

10.2  Methods:

  • Quantitative
  • Qualitative

10.3 Study Types

10.3.1 Non intervention ( non experiment) Studies.

  • Exploratory
  • Descriptive ( case studies / cross-sectional )
  • Comparative or analytical ( cross- sectional / case control / cohort )

10.3.2  Intervention ( Experiment )

  • Pre-experimental ( one group pretest/ post test design)
  • True experimental design ( pretest/post test control and experimental group design with randomization)
  • Quasi-experimental ( pretest / post test control and experimental group design without randomization or non-equivalent control design

10.4  Variables

  • Qualitative variables.
  • Quantitative variables.
  • Dependent variables.
  • Independent variables.
  • Confounding ( extraneous ) variables.
  • Back ground ( attribute ) variables.
  • Intervening ( modifying ) variables.

10.5 Criteria 

  • Inclusion criteria
  • Exclusion criteria

10.6 Sampling

  • Target population/ Sampling population
  • Sampling units ( Geographical: a district, a city, a ward etc, Structural: a house, a flat etc,  Social: a family, a school etc  and Individuals.
  • Sampling frame/ List : Should be up to date/ should contain full information about the units, and should be reliable.

10.7 Sample Size

  • Should fulfills the requirements of efficiency, representativeness, reliability and flexibility.
  • Should be small enough to avoid unnecessary cost and large enough to avoid intolerable sample errors.
  • Write formula for sample size calculation.

10.8a Non Probability Sampling

  • Convenience ( haphazard) sampling
  • Quota sampling
  • Purposive ( judgmental) sampling
  • Snowballing sampling

10.8b Probability Sampling

  • Simple random sampling ( with replacement or without replacement )
  • Systematic sampling
  • Stratified random sampling
  • Cluster sampling
  • Multistage sampling

10.9a Data Collection Techniques

  • Using available information
  • Observing
  • Interviewing ( face to face )
  • Administering written questionnaires
  • Focus group discussion

10.9b  Plan for Data Collection Process

  • Permission to proceed: Write for ethical clearance informed consent etc
  • Data collection: Write logistic for data collection- who will collect what data? How long will it take to collect data for each component of the study? In what sequence should data be collected?
  • Write about ensuring quality and data handling.

10.9c Plan for Data Processing  and Analysis

  • Write about sorting data, performing quality-control checks, categorizing, coding/decoding etc.
  • Computer or manual compilation of data
  • Statistical presentation and test
  1. Work Plan
  • Duration of study
  • Tentative date of starting the project
  • Working schedule/ Gantt chart
  • Plan for project administration and monitoring including description of project staffs
  1. Expected outcome of the study and utilization of the research findings
  2. Dissemination plan
  3. Budget: Include  explanatory note on  major budget items
  1. Facilities :
     What are available and what are not available if to be purchased and specify correctly.
    16. Name of Principle
  • Investigator (PI) and
  • Co-investigators
  1. Correspondence Address
  • Include postal address
  • Telephone number
  • Fax number
  • E-mail address/ website etc
  1. Annexes
  • References/ bibliography
  • List of abbreviations ( if necessary )
  • Data collection instruments ( including questionnaire)
  • Informed consent format
  • Curriculum Vitae of Principal investigator and co-principal investigators

A Review Article

 “Study on clinically important  Medicinal Herbal plants researched dated 2013-2014 indexed in PUB-MED”

– Regmi P., Ayurveda Campus, Institute of Medicine

 A lots of herbal pants possesses a great therapeutic value and is widely distributed in Nepal ranging the lower  altitute Terai to the High altitude Alpine Region. Ayurveda is the indigenous system of medicine  for over thousands of years.  Ayurvedic medicine have played and still play an important role in fighting against various diseases (1). A lots of Ayurvedic formulations are formulated based on reference to the classical text considering the properties, uses and the doses. An ayurvedic system of medicine a vast number of medicinal plants are reported to possess a lots of functional importance . A lots of potent drugs are formulated based on the previous studies revealing remarkable phytoconstituents. This study is based on the review on the scientific proofs to the medicinal plants mentioned in the classical regarding their phytochemical importance.

 Ashwagandha (Withania somnifera) contains compounds with sedative effects on the central nervous system. These results also suggest potential target for modulating orofacial pain processing(2). Its root powder also acts as an anti-inflammatory and antioxidant agent in decreasing the arthritic effect (3). The leaves is effective for the cancer treatment. It is cytotoxic to cancer cells selectively, and causes tumor suppression in vivo. Its active anticancer component was identified as triethylene glycol (TEG). Molecular analysis revealed activation of tumor suppressor proteins (4) Molecular targets and mechanisms of active steriodal lactone called Withanolides likely contributing to the anticancer(5). It has potent antioxidant, anti-inflammatory, pro-apoptotic, and cardioprotective effects(6). A preparation “super curcumin” containing Curcumin as  the main ingredients,  is used as a natural product to curing of diabetes. (7). Curcumin (diferuloylmethane) is potential candidate for lung cancer. Curcumin has been widely studied for its anticancer properties via its effects on a variety of biological pathways involved in apoptosis, tumor proliferation, chemo- and radiotherapy sensitization, tumor invasion, and metastases (8).  Terminalia fruits [Terminalia bellerica Roxb. (Combretaceae) and T. chebula Retz. (Combretaceae) has most effective role in stimulating glucose, acting increased insulin-stimulated glucose uptake without inducing the adipogenesis  &  being most effective in increasing PPAR protein expression (9). Mucuna pruriens  can be used an effective treatment for neurodegenerative diseases, especially Parkinson’s disease by decreasing oxidative stress and possibly by implementing neuronal and glial cell crosstalk(10). Brahmi Ghrita containing Bacopa monneri as the major ingredients produced significant beneficial effect on scopolamine-induced amnesic effect (11) . Bacopa monnieri has improved congnitive function on the neurological and behavioral defects especially on the dementia patients(12). It has the significant role on memory enhaancer. It plays a neuroprotective role against PBDE-209-induced alterations in oxidative status (13) Ixora coccinea has the potent anti-neutrophil activity & anti-inflammatory activity so can be used for acute bronchitis, reddened eyes and eruptions and dermatological disorders(14). Coconut oil has  potential beneficiary effect on adjuvant induced arthritis in rats and the mechanism behind this action is due to its antioxidant and anti-inflammatory effects (15). C. aromaticus (Pashanbed leaves) as “Pashanbhed”; is  most effective diuretic drug and lithotropic drug, used to treat renal problems. Other diuretic drugs can be Kalanchoe pinnata, Coleus aromaticus (16). Cleome viscosa L. (Cleomaceae) promoted the wound repair process by attenuating the collagen production in wound granulation tissue (17). Curcuma zedoaria (family Zingiberaceae) ethanolic rhizome extract has central and peripheral analgesic and anti-inflammatory activity(18). Bilvadileha has effectiveness in the management of irritable bowel syndrome (19). Cissus quadrangularis treatment is effective against diabetes-induced delayed fetal skeletal ossification(20). The roots of Ichnocarpus frutescens has  showed significant anticancer activity(21). Salacia reticulata Wight (S. reticulata) is a herbal medicine used for treatment of early diabetes. It has effects on obesity and metabolic disorders by enhancing lipogenesis genes and suppressing lipolysis genes through the activation(22). Guduchi (Tinospora cordifolia [Willd.] Miers) has  highly potent anti-diabetic (mild hypoglycemic insignificant anti-hyperglycemic activities)(23). Stems of  Tinospora cordifolia management of diabetes. Stem extracts are able to promote glucose uptake through glucose transporters, 1 (GLUT1) and 3 (GLUT3), which are responsible for basal glucose uptake(24). It has antidiarrheal and antiulcer activity. It  extracts are more efficacious in reducing number of total stools in both the models of diarrhea and property of  dose-dependent antidiarrheal effect. Ulcer index is reducted along with the decrease in gastric volume, total acidity, and an increase in pH of gastric content in both the models(25). Tinospora cordifolia, Alstonia scholaris, Crataeva nurvala) shows antimicrobial effect.  T. cordifolia and A. scholaris exhibits a higher inhibitory activity against clinical isolates of MRSA and carbapenemas -producing K. pneumoniae. And antifungal activity towards Candida albicans observes for A. scholaris extract(26)  . Roots of C. pareira has exhibited a significant antiurolithic effect against urolithiasis in experimental rats(27).  Justicia adhatoda (vasaka) leaves acts as hepatoprotective (recovery of liver function)(28). Aerva lanata has antidiabetic property (Alpha glucosidase inhibition, antiglycation, and adipogenic potential). In addition insulin sensitization and antioxidant potential also enhance its therapeutic potential (29). Lepidium sativum Linn. (Chandrashura)is used for treating inflammatory condition like arthritis. It has strong inhibitory effect on proliferation of fibroblasts and connective tissue modulation effect(30). Tectona grandis flowers has antidiabetic action. It has an insulin-sensitizing action, as well as inhibition of alpha-amylase and alpha-glucosidase activity (31). The root bark of Grewia asiatica Linn. (Family: Tiliaceae  has beneficial treatment in rheumatism (painful chronic inflammatory condition). It exhibits peripheral and central analgesic effect and anti-inflammatory activity(32), Cuscuta reflexa is used for hair growth promotion. It is capable of promoting follicular proliferation or preventing hair loss in cyclophosphamide-induced hair fall (33). Flacourtia indica anticancer effects  & effective in the suportive treatment  in human colon cancer. It  has anti-proliferative and pro-apoptotic effects in  human colon cancer (HCT116 cells) and the effects are, at least in part, due to the reactive oxygen species (ROS) dependent activation of caspases(34). Nymphaea nouchali is used for the treatment of diabetes, cutaneous diseases, inflammation, liver disorders, urinary disorders, menorrhagia, blenorrhagia, menstruation problem, as an aphrodisiac, and as a bitter tonic as antimicrobial agent. It has catechin in abundance along with other active compounds for the treatment of infections(35). Phyllanthus amarus is evaluated for anti-inflammatory and analgesic potential (36). leaf extract of Costus speciosus  has potential for natural therapeutic product development for hepatocellular carcinoma(37). It has noncytotoxic, anti-inflammatory action, immunomodulatory activity (38). Azadirachta indica leaves has antifilarial activity. It causes a decreased expression of anti-apoptotic genes and increased pro-apoptotic gene expression at the level of both transcription and translation (39). Resin extract of Commiphora mukul is ailments including lipid-related disorders such as obesity and arteriosclerosis. significantly decreased the plasma ghrelin, glucose, triglyceride levels and increased plasma leptin, serotonin, dopamine levels (40). Vitex negundo Linn. , Oroxylum indicum Vent.  and Barringtonia acutangula Linn. has Nephroprotective activity. It significantly attenuated the nephrotoxicity by elevation of body weight, Catlase, Glutathione peroxidase and Superoxide perioxidase or lowering urine LDH and creatinine, serum urea; serum creatinine and Lipid perioxidation (41). Andrographis paniculata (AP) is used for treatment of liver diseases especial in alleviating hepatosteatosis in chronic alcoholism. It is capable of preventing the development of fatty liver through AMP-activated protein kinase (AMPK-mediated) regulation of lipid metabolism(42). Ipomoea sepiaria Koenig Ex. Roxb has laxative activity as it is rich in purgative resins. Root & leaf have marked intestinal motility enhancing property (43). Nardostachyos Radix et Rhizoma (NRR; the root and rhizome of Nardostachys jatamansi DC.) is used in treatment of cardiovascular disorders. It has volatile oil prevented the oxidative stress-induced cell death in H9c2 cells by reducing intracellular ROS (reactive oxygen species) production, inducing antioxidant enzymes and activating phosphorylation (44). Swertia corymbosa is used for the treatment of diabetes. The aerial parts is effective as anti-diabetic and antioxidant activities(45). Mallotus philippinensis anti-allergic and anti-helminthic treatments and effective in prostate cancer treatment. The Rottlerin (Rott) having autophagy modulators has the potential for facilitating the development of autophagy-based therapeutic interventions for prostate cancer (46). Roots of Plumbago zeylanica Linn is used for the treatment of arthritis. It paste prepared shows significant antiinflammatory activity support its utility in arthritic pain, inflammation (47). Gymnema sylvestre (GS) (Asclepiadaceae) are the most important medicinal plants for the treatment if hyperglycemia.Its hypoglycemic action attributed through an increase in plasma active Gucagon like peptide (GLP-1) levels (48). Achyranthes aspera has anti-inflammatory activity (49). Lannea coromandelica is used in various microbial origin disorders like dysentery, sore eyes and leprosy, genital wounds. It has antibacterial activity against S. pyogens, S. aureus and antifungal property against C. albicans (50).. Moringa oleifera Lam. (Moringaceae) is used to treat paralysis, nervous debility and other nerve disorders along in addition to its nutritional value. It promotes axodendritic maturation as well as provides neuroprotection suggesting a nutritionally important and ethnomedically stimuant for the nervous system(51).  Careya arborea Roxb. has  ulcers, healing of wounds and several skin diseases.extract of C. arborea leaves (CALE) has gastroprotective effect  due to ots radical scavenging activity (52). Ocimum sanctum is a plant which has the greater medicinal value for dental plaque, gingival inflammation. It is effective mouthwash owing to its ability in decreasing periodontal indices by reducing plaque accumulation, gingival inflammation and bleeding(53). Emblica officinalis acts as anti-inflammatory agent inhibiting edema against all phlogistic agents and also reducing granuloma formation(54). Azadirachta indica leaves has the significance imortance on induced colitis. It has enhancing property of  the antioxidants but decreasing free radicals significance(55) (56). Neem (Azadirachta indica L.) leaf regulates female fertility. It induces generation of Reactive Oxygen Species and mitochondria-mediated apoptosis both in granulosa cells as well as in follicular oocyte (57). Cinnamomum tamala has beneficial effect on  prostate disorder (Prostate Hyperplasia)  by virtue of inhibition of androgen mechanisms in prostate and modulating inflammatory mediators in prostate(58). Aloe- vera gel ethanolic extract is used in the diabetic foot ulcer (DFUs).It reduces the blood glucose, improves the plasma insulin, and significantly increases DNA and glycosaminoglycans (GAGs) to improve the wound ulcer healing as well as the breaking strength (59). Cedrus deodara and Pinus roxburghii has the memory-enhancing activity. Deodara has  strong antioxidant properties from compounds like terpenoids and flavonoids. Piper betle Linn. (Piperaceae) is used as a remedy for gastric ulcers. It increases the mucus content adhering to the wall of the gastric mucosa and inhibits the volume of gastric acid without increasing acidity (total and free) and pH of the gastric juice (60).

The review also gives an account of selected patents on various important activities of phytochemicals.  In view of its varied therapeutic potential, the plant has need to  be in  the subject of considerable scientific attention. Moreover, as a traditional medicinal plant, it is still potential for its phytochemical components that increase the demand of further extensive evaluation to justify its other therapeutical roles. Pharmacological effects, dose-response relationship and toxicological investigations to assess potential for acute or chronic adverse effects should be further investigated. The experimental results, the precise mechanism of action, the compound or extract toxicity, and the dose to be administrated for an optimal effect need to be investigated. Also human trials (some preclinical studies proved to be remarkable) should be further investigated. The lots of plant species  are  useful not only in medicine but also in other domains which makes it a high value-added plant. The physico-chemical and pharmacological analysis can only confirmed its use as a safe clinically important ayurvedic formulations. Therefore,  effort is must to be made by the researchers  to disclose the unjustified phytotherapeutical role of a herbal medicinal plants. Hence a detailed review has been carried out on different varieties of ayurvedic potent clinically specified herbal species.

 Reference

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THE REVIEW OF RESEARCH IN AYURVEDA

The background:

With the awakening of the human mind to the super-sensual reality behind life, he felt the need to propitiate by conduct and ceremony regarding the mysterious aspect of life. From then Ayurveda has attained his age of maturity emerging from its nonage of Vedic medley of charms and simple drugs, of the incantation of magic ritual, into the maturity of rationally expounded science of health and disease and a systematic practice of remedies.

The continuity of tradition which Ayurveda has enjoyed is the continuity of growth not of mere survival. This lasted from the time of Atreya upto the end of seventeen century after Christ. It was therefore a process of scientific development and not as a mere mechanical process operating on the basis of collective drill and training. The value of knowledge and consequently of education was fully realized by the early ancestors of our race. Knowledge was indeed so highly prized by the scholar that they dedicated their whole lives to the pursuit of learning living away from the distraction of the world.

Gradually the different facts gathered  by the seeker, developed into a science of life and the scientist, the sages devoted themselves to their  search with all-dedicated inspired enthusiasm , often extending all through their life. In due course of time they imparted what were revealed to them in their contemplation, to their succedor.  These disciples in their own way checked and rechecked the truth, given out to them in the light of new data   to make a more scientific and reliable conclusion. Thus a body of ‘subjective truth’ in time developed into precise science and these honest and sincere scholars always try to communicate their contemplative experience and the consequent conclusion upon the meaning and purpose of life to the peoples of the world.

When this transcendental experience was confirmed and attested by many more scholars it gained the status of a verified and proved, determined and demonstrated scientific fact.

The flow of research

Ayurveda, the science of life, is an eternal flow of knowledge which transcends from the time immemorial for the benefit of humanity. Lord Brahma inculcated and compiled the entire ayurveda wisdom in his Brahma–Samhita having thousand chapter and hundred thousands verses[i]. In due course of time this uninterrupted knowledge has emerged as beneficial and acceptable wisdom through various phases of metamorphosis. Various scholars of different eras have tried to enrich this science and make it more practical with their traditional wisdom, clinical and experimental research. Gradually it becomes janopayogi, explorative and time-proven (kalajayi).   In this regards various experiments have been carried out on the basis of classical principles and the science has been enriched with the incorporation of the results of those experiments.

   In those research experiments different alterations were made according to the need. Sometimes minute modifications in the approach, procedure, in the preparation of medicine, in the combination of medicine were adopted for making the treatment more convenient, more effective and also more adaptive for the era. The commentators, in their respective commentaries, have tried to explore the hidden unexplored and difficult portion of classics with their own clinical and research experiences.

Hence it reveals that textual literary research, experimental and clinical researches are mandatory to maintain the stream-line flow any research.

Example :

In the phases of metamorphosis, the principles, formulation, etc. have been repeatedly examined through a series of experimentation and conclusion has been drawn on the basis of outcome of the research[ii]. The evaluated and approved principles and formulations etc. have been implemented later on. In the course of time, the implemented matters have been again subjected for re-evaluation.

Following example can be taken for an example.

 The ointment of the leaves of muder (calotopis procera), the stalks of throny milk hedge (euphorbia ) and the sprout of bottle gourd(katuka), and Indian beech, prepared in goat’s urine, is depicted as an excellent application for piles[iii] in caraka samhita.  In some editions of caraka samhita the reading of milk of muder is also available[iv] which suggests that this practice was also being used by some school of physicians and researchers. The author of astanga hridaya has justified this research and implemented this portion of verse as ‘milk of muder’[v]. This alteration also favours to prepare the desirable paste. The research in this regards has been continued for next five hundred years and aharya cakrapanidutta has further changed this preparation and the milk of both  muder and throny milk hedge have been advocated instead of the leaves of muder, the stalks of throny milk hedge respectively[vi]. Various practical angles regarding the use of parts of the plants, the preparation and affectivity etc. have been re-evaluated in this research process.   

Discussion
            Some of the highest intellects tried their level best to accelerate the outflow of the knowledge of the original medical text overcoming the time-bound adversities[vii]. Those scholars magnified the views of the text through scientific and valuable up-to-date clinical experiments by which even the comparative middle and low intellects could be able to grasp the entire knowledge transparently[viii]. The basic theme was truly versed by the stalwart professionals and accordingly commented on textual hidden perfections with the clinical outlook which was in practice[ix]. Therefore, this amplification of the subject was properly and scientifically inculcated by the disciples and practiced thoroughly because of the time proven validity[x].

            The knowledge is intensified with proper justification[xi], the professionals knowledge is dignified with practical application[xii], and specifically the medical knowledge is accelerated with several clinical practices and profound justification[xiii]. The clinical applications always prove its fruitfulness justifying the ambit of basic sciences like physics, chemistry, and biology along with anatomy, physiology, and biochemistry etc. The ultimate is to treat the disease either in preventive or in curative aspects[xiv].

Conclusion

On the basis of above discussion it may be concluded that the research is the life-line for any science especially medical science. The ever-flowing ancient medical texts are metamorphically analyzed with the thoughts of different commentators of different times and existing due to the relevancy with sound, appropriate and varied day to day applicability.  Researchers and commentators on the basis of their wisdom[xv] use to enhance the utility of science for better acceptance time to time. This nourishes the clinical and technical wisdom and makes the subject acceptable and fit for the respective era. This is continuing from the very beginning and today in the era of technology also this flow of research exploration in all corners of ayurveda is mandatory.       

 

[i] Sushruta, Sutrasthana , 1st chapter, 6th  shloka, Sushruta Samhita, Nibandhasamgraha commentary by Dalhana, Yadavji Trikamji Acharya editor,Chaukhamba Orientalia, 6th edition,1997, pp 2

[ii] Agnivesh, Vimansthan, 8th Chapter, 37th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 268

[iii] Agnivesh, Cikitsasthan, 14th Chapter, 57th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 504

  ¡rka¯ patra sudh¡k¡³¢a¯ ka¿uk¡l¡bupallav¡¦|

                        kara²jµ bastamÀtra¯ ca l£pana¯ ¾r£½¿hamar¾as¡m||57||

[iv] ’ ¡rka¯ paya¦ tra sudh¡k¡³¢a¯’ – gangadhar commentary edition

[v]  Vagbhat , cikitsasthan , 8th chapter, 25th verse, Ashtanga Hridaya, Sarvangasudara and Ayurveda Rasayan Commentary of Arundutta and Hemadri,Bhisagacharya Harishastri Paradakara Vaidya editor, Chaukhamba Orientalia, 8th edition,1998 page 645

[vi]  Cakrapanidutta, arshocikitsa, 5th chapter, 5th shloke, cakradutta with ratnaprabha commentary of Nischal kara, PV Sharma editor, Svami jayaram Das ramprakash Trust, jaipur 1st edition, 1993, pp 161

[vii] Madhav, Ashonidana, 5th Chapter, 9th verse, Madhavnidanam, Madhukosa commentary of Vijayrakshita and Srikanthadutta, Pt. Brahmashankar Shastri Bhisagratna editor, Chaukhamba Sanskrit Samsthan, 3rd Edition 1993, page 1-2

[viii] Agnivesh, Sutrasthan, 1st Chapter, 1 Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 1-3

[ix]  Agnivesh, Sutrasthan, 1st  Chapter, 28th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 7

[x]  Agnivesh, Sutrasthan, 1st Chapter, 30-35th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 7-8

[xi] Agnivesh, viman sthan, 4th Chapter, 8th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 248

[xii] Agnivesh, Sutrasthan, 9th Chapter, 18th Shloka , Caraka Samhita, Cakrapani Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 64

[xiii] Agnivesh, Sutrasthan, 9th Chapter, 6th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 63

[xiv] Agnivesh, Sutrasthan, 30th Chapter, 26th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 187

[xv] Agnivesh, Vimana, 6th Chapter, 4th Shloka , Caraka Samhita, Ayurveda Depika Commentry by Cakrapanidutta, Pt. Yadavji Trikamji Acharya editor,Rastriya Sanskrit Samsasthan , Reprint 2006 Page 253 

Acknowledgment: http://ayurvedahin.blogspot.in/

 

INTELLECTUAL PROPERTY RIGHTS & TECHNOLOGY TRANSFER

Intellectual_property_rights_

Intellectual  pdf link 

NATIONAL ETHICAL GUIDELINE FOR BIOMEDICAL AND HEALTH REAEARCH INVOLVING HUMAN PARTICIPANTS

 

Clinical trials on traditional systems of medicine
Although traditional systems of medicine (termed complementary and alternate
systems in the west) are known for their long history of safe and effective use,
validation of safety and efficacy using scientific and evidence-based methodologies is
needed for the purpose of universal acceptability, gaining confidence of practitioners
and satisfaction of end users in the products. Government of India has recognized
Ayurveda, Siddha, Unani, Yoga, Naturopathy and Homeopathy as traditional Indian
systems of medicine. In 2012, Sowa Rigpa (Amchi or Tibetan medicine) was also added
to the list. Ministry of AYUSH (Ayurveda, Unani, Siddha and Homeopathy) governs
and regulates these systems. Drugs under these systems come under the Drugs and
Cosmetics Act, 1940, as ASU and H drugs. Drugs/formulations under these systems
of medicine are classified into two groups. See Box 7.7 for further details:
7.13.1 Research on AYUSH and ASU interventions of traditional medicines (TM) including
external medicines/therapeutic procedures, folk medicines, and patent and proprietary
medicines of TM involving human participants should be conducted in accordancewith all the ethical principles described in these guidelines including SAE reporting
and compensation, AYUSH GCP guidelines32, as well as other applicable regulations
of the country

Classification of drugs/formulation under AYUSH

1. Classical preparations/formulations are those that are to be clinically evaluated for the same indication for which it is being used or as has been described in classical authoritative texts.
These classical drugs are manufactured and named in accordance with the formulations described in the authoritative texts.
2. Patent or proprietary products are formulations containing only such ingredients
mentioned in the formulae described in the authoritative books of Ayurveda (or Yoga, Naturopathy, Unani, Siddha, Homoeopathy, SOWA–RIGPA systems, as the case may be), medicine specified in the first schedule, but differ to create a new combination, or use innovation or invention to manufacture products different from the classical medicine. However, this group does not include a medicine which is administered by parenteral route.

.

.2     If IPs/comparators of  more than one traditional system of  medicine are t investigated, then investigator(s) from the respective systems should be include the study as co-investigator(s).

.3    The EC must co-opt a person with relevant expertise (an expert of that traditional syst of medicine) to review theproposat especially the benefits and risks of the interventi eligibility criteria, doses of interventions, outcomes planned and traditional met of evaluation, if necessary.

.4     When a folklore medicine/ ethnomedicine is ready for commercialization after it been scientifically found effective, benefit sharing should be ensured and the legitim rights/share of  the  tribe or  community from which the  knowledge was gathe should be taken care of appropriately while applying for the IPRs and patents for product. while conducting trials using intervention(s) of traditional

 

 

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