صفحه 1:
www.tabaye.ir
صفحه 2:
Clinical Trials of
Traditional Herbal
Medicines In India
Y.K.Gupta
Professor & Head,
Department of Pharmacology,
All India Institute of Medical Sciences,
New Delhi
صفحه 3:
Introduction
٠ Use of traditional medicines (TM)
remains widespread in developing
countries like India
* Use of complementary and
alternative medicine (CAM) is
increasing rapidly in developed
countries For the use of large
animals, permission to be obtained
from Chennai office.
صفحه 4:
What includes Traditional
Medicines? 5
Diversity of health practices, approaches,
knowledge, and beliefs incorporating
plant, animal, and/or mineral-based
medicines; spiritual therapies; manual
techniques; and exercises, applied
singly or in combination maintain well-
being, as well as to treat, diagnose, or
prevent illness
>
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Potential Risks
* Direct risks of adverse effects and
drug interactions
¢ Indirect risk that an traditional
remedies without demonstrated
efficacy may compromise, delay or
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conventional treatment.
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Risks....
* Hazardous in specific patients
under special circumstances
or when combined with
conventional drugs.
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Categories of Herbal
Drugs
* The substance is ات clinically
evaluated for same indication for which it
is being used or as has been described in
the texts.
* b. An extract of a plant or a compound
isolated from the plant has to be clinically
evaluated for a therapeutic effect not
described in the texts of ی
traditional systems- new chemical entity
o ie been in use before and has not ever
been mentioned in ancient literature.
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Concerns about Clinical
Study Designs
* Methodological quality is variable
* Quality of the trial drug has to be
tested for batch-to-batch uniformity
of the active constituents
* Source, processing, and final
composition of the herbal product
٠ Herbal trials generally use placebo
and not an active comparator
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Concerns about Clinical Study
۱920
¢ Study should be adequately
ات۱
* Combined use of an herbal
medication and a conventional
drug considered in clinical trials
¢ Adequate doses of both herbal
drug and active comparator to
ع2 50
صفحه 10:
Benchmarks Of A
Clinical Trial Using
ال ان ةا
Medicines
If Design of the trial is appropriate
to provide the expected outcomes
for the traditional medicine.
Whether the methodology limits
the treatment procedure of
traditional medicine.
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Benchmarks Of A Clinical
۹01
Herbal/Traditional
Medicines........
¢ In order to avoid the loss or alteration of the
efficacy of the substance, validated methods
needed while adapting modern method to
formulate and dispense the medicaments.
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Challenges
* Regulatory Status
¢ Assessment of safety
* Efficacy
* Quality Control
صفحه 13:
Regulatory Requirements For
The Conduct Of Clinical Trials
on Herbal Medicines
* Traditional medicines are governed by
the Drugs and Cosmetics Act of 1940
and the Drugs and Cosmetics Rules of
* In 1959, the Government of India
amended the Drugs and Cosmetics Act
to include drugs which are derived
from traditional Indian medicine
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Regulatory Requirements.....
* In 1993, the guidelines for the safety
and efficacy of herbal medicines
developed by an expert committee
* No new herbal medicines other than
those authorized by the licensing
authorities be allowed to be
manufactured or marketed, except
for those mentioned in ancient
scriptures
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Regulatory Requirements
The procedures laid down by
the office of the DCGI for
allopathic drugs should be
followed for all traditional
and herbal products to
0 و
any therapeutic condition.
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Regulatory Requirements.....
* Co-investigators/collaborators of
the expert group are from the
associations of physicians from the
concerned system for designing
and evaluating the Study.
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Phases of Clinical Trials
* Phase I studies may not be necessary
* Need for testing its toxicity in animals
has been considerably reduced.
* Toxicity study may not be needed for
phase II trial unless reports suggesting
toxicity/herbal preparation is to be
used for more than 3 months
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Phases of Clinical
Trials...
¢ Larger multicentric phase III trial
is subsequently planned based on
results of phase II study.
¢ These trials have also got to be
approved by the appropriate
scientific and ethical committees
of the concerned Institutes
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Challenges which need to be
addressed
* Quality control of herbal medicines is
complicated and difficult
* Relevant appropriate requirements
should be established for the
assessment of safety and efficacy for
different categorized herbal medicines
to reduce cost and expenditure
¢ Integration of traditional medicine into
national health systems