1. Introduction:
Ayueveda, the veda of science, has specified three natures for human body, named Vata, Pitta and Kapha. Modern Science has recently discovered that these natures are genetic. Hence, this Prakriti creates a strong base for deciding the disease and then curing it afterwards. Besides this, Herbal medicines are also a majour remedy in our traditional ayurveda medical system, espically in developing countries.
On the other side, Clinical research is a systematic study of new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including Pharmacodynamic and pharmacokinetic) or adverse effects and with the objective of determining safety and efficacy of the new drug.
It has capability of evaluating the efficacy of selected simple drug, simple herbal and herbo-mineral preparations.
WHO not only supports the appropriate use of herbal medicines, but also encourages the use of remedies, proven safe and effective.
2. Clinical-research and ayurveda:
Ayur means “Life”
Veda means “Knowledge or Science”.
Similarly, Clinical- research means “Examination of scientific-study of drugs on human-beings”
Therefore, Clinical-research and Ayurveda are correlated, both aiming at diagnosing and treating humans’ lives.
3. Ayurvedic drug: Boon or Curse
Journal-of-American-Medical-Association (JAMA) has recently published findings of a study, performed by JAMA on 14 commercially available Ayurvedic medicinal products sold in the
Moreover, Canadians banned the use of some ayurvedic drugs as these had high content of lead, arsenic and mercury. Toxic effects of lead, arsenic, mercury and other element may cause serious hazards to body. For e.g. Lead may cause abdominal pain, weakness, insomnia and kidney damage. Mercury can cause memory loss and brain and kidney damage, thereby deteriorating human health.
Hence, while preparing any ayurvedic drug, it should be well checked with respect to the quality and quantity of various raw materials used in it such as metals, herbs etc.
4. Ayurvedic drugs, more research and development needed:
The WHO has published guidelines in order to define basic criteria for evaluating the quality, safety, and efficacy of herbal medicines aimed at assisting national regulatory authorities, scientific organisations and manufacturers in this particular area (WHO, 2000). Furthermore, the WHO has prepared pharmacopoeia monographs on herbal medicines and the basis of guidelines for the assessment of herbal drugs (WHO, 1999, 2001).WHO guidelines for Good Clinical Practice (GCP) are adapted from ICH guidelines.
The WHO guidelines on good agricultural and collection practices (GACP) for medicinal plants are an important initial step to ensure good quality, safe herbal medicines and ecologically sound cultivation practices for future generations.
Though the experience obtained from the traditional use of herbal medicines over the years should not be ignored, most of these still need to be studied scientifically. In today’s world, the rational use and development of herbal medicines will be further supported by appropriate scientific studies of these products.
General considerations that should be kepk in mind while defining and evaluating the herbal medicinal research are:
-> Legal research,
-> Ethical research
-> Research on humans and animals,
->Respect for environment, and
-> Traditional knowledge of herbal medicines.
Moreover, following are the principles (based on traditional principal such as Ayurveda) and techniques that should be considered while conducting research on herbal medicines:
->Rregulatory requirments,
-> Purpose of research,
-> Selection of research projects,
-> Research approaches,
-> Knowledge of complete literature background,
-> A carefully planned protocol, and
-> The quality of plant material
Additionaly, general pharmacological investigations are conducted to explain various pharmacological activities. Such investigations usually cover the tests on nervous, cardiovascular and respiratory systems etc.
Systemic toxicity tests can be performed. These tests refer to alteration of either physiology, anatomy (gross or microscopic) or clinical chemistry (including haematology) that results from pathological changes in any organ distant from the site at which a herbal medicine is administered.
Local toxicity tests can be performed to determine the local irritation and/or systemic absorption of a herbal medicine used for local applications (such as respiratory inhalants, drugs applied to skin or mucosa).
Hence, it is crucial that all the above factors are integrated and a strategic approach to validate Ayurveda into a globally acceptable and viable complementary healthcare system ensuring drugs’ safety and efficacy be developed. This will benefit millions of patients, to whom modern medicines have not been able to provide adequate relief from ill-health.
All these issues need to be addressed by the Ayurvedic industry along with academic research laboratories involved with this system of medicine. Though, due to the nature of the system and its products, it would not be possible to harmonize the system among all producers of Ayurvedic drugs and make them usable by all practitioners of Ayurveda, it is necessary that at least:
è convincing evidence of quality, efficacy and safety should be there
è types of patients should be noted down, on whom these drugs are to be used
è diseases noted down for which these drugs are used,
è dosage recommendation is mentioned,
è duration of treatment is mentioned, and
other such important considerations that have a bearing on the toxic effects of these drugs, are provided for all products marketed for human consumption.
5. Clinical-research on ayurvedic-therapeutics
If ayurvedic-therapeutics has to compete with new chemical-entities and biotechnology-products, it must focus on utilizing principles and practices of modern clinical- trials, using herbal medicine.
Clinical trials, which are conducted in four phases should be scientifically sound, and should be described in a clear and detailed protocol. These clinical trials of herbal medicines may have two types of objectives.
è To validate the safety and efficacy that is claimed for a traditional herbal medicine.
è To develop new herbal medicines, examine a new indication for an existing herbal medicine and change dose formulation or route of administration.
In some cases, trials may be designed to test the clinical activity of a purified or semi-purified compound derived from herbal medicines.
Globally, there is an increasing interest in Ayurveda as an alternative route to health. Hence, there is a need to conduct globally acceptable clinical research in ayurvedic therapeutics (AT). Some of the issues in investigating AT in randomized clinical trials (CT) are:
· Selection of appropriate AT
· Identification of objective outcomes
· Devising adequate placebo/positive controls
· Duration of trials
· Number of patients
· Dose optimization, etc
5. Conclusion:
As we have seen the ill effects of ayurvedic drugs in the section ’ boon or curse’, we should realize that to ensure more quality of ayurvedic drugs, it is necessary that more research and development is done in ayurvedic medicines. If we can accurately check each drug during its making, we can greatly reduce the negative effects of such drugs. To implement the same and reduce the poisonous nature of these drugs, it is required that more research is done in this field using modern techniques.
To communicate Ayurvedic effectiveness and curative-properties to world, Ayurveda needs more research and development. Hence, I strongly believe that Clinical-research with ayurveda, will take ayurveda to new heights of success.
1. Guidelines for the assessment of herbal medicine programme on traditional medicine.
2. Guidelines for reproduction studies for safety evaluation of drugs for human use.
3. 1990 Guidelines for toxicity studies of drugs manual/editorial supervision by New Drugs Division, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare.
4. Clinical research on new drugs (traditional Chinese medicine).
5. Proposed WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products WHO drug information 1992. 6(4) 170-188
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