Traditional Medicine in Asia

Standardization, preclinical toxicology and clinical evaluation of medicinal plants, including ethical considerations
herbal medicines. The programme, first
described by the author at a meeting on
Alternative Medicine organized by the
National Institute of Health in Washington
in August 1977, is monitored by a Scientific
Advisory Group consisting of persons from
the Allopathic, Ayurveda and Unani systems
of medicine. This group also contains
experts in pharmacognosy, toxicology,
pharmacology and clinical pharmacology
as well as clinicians and experts in
standardization and quality control.
The infrastructure consists of the core
group at the ICMR Headquarters at New
Delhi, three Advanced Centres in
Traditional Medicine and different expert
groups for every condition being studied.
There are, for example, at this time special
expert groups for bronchial asthma,
arthritis, hepatitis, benign hypertrophy of
the prostate, filariasis and cancer. The three
Advanced Centres are at the Central Drug
Research Institute, Lucknow (Pharmacology
and Clinical Pharmacology), the
National Institute of Epidemiology, Chennai
(Preparation of protocols, randomization
and monitoring of results), and at the
Regional Research Institute, Jammu
(Standardization). There are specialized
centres in the network such as the
Institute of Himalayan Ecology at Palampur
for the study of special features of medicinal
plants needing study, the National Institute
of Education and Pharmaceutical
Research, Chandigarh (Bioavailability
Studies) and the Central Indian Medicinal
Plants Organisation at Lucknow (growing
medicinal plants). In addition, there are
more than 25 clinical trial centres spread
throughout the country for carrying out
multicentred studies.
The trials are planned and protocols
prepared by the whole group. All trials are
comparative, controlled, randomized and
double-blind unless there is reason for
carrying out a single-blind study. No
compromise is made on the quality of the
scientific clinical trials. Although the trials
are planned by the multidisciplinary central
group, they are carried out at the foremost
centres of allopathic medicine in the
country. This is the reverse of the Mumbai
studies where the clinical evaluation is
being carried out at the Ayurvedic hospital.
The Chief Investigator of any one study is
always an outstanding clinical researcher
in the field. The results obtained are
monitored by the whole group. Only
standardized preparations with predetermined
markers are used for these trials.
Using this network, the Council has
demonstrated that a medicated thread
coated with Euphorbia neriifolia (Snuhi),
Achyranthes aspera (Apamarga) and
Curcuma longa is as effective as surgery
for the treatment of anal fistula. 22 The
Council has also shown that Picrorhiza
kurroa is effective in hepatitis 23 and that
Pterocarpus marsupium is again an
effective anti-diabetic drug. 19 Pterocarpus
marsupium will soon be handed over to
the industry for marketing. The results of
these clinical trials will be acceptable to
clinicians at allopathic hospitals because
of the sophisticated clinical pharmacological
methodology used in these trials
with only well- standardized products.
Selection of patients
In any clinical trial the right drug has to be
given to the right patient. In allopathic
medicine all cases of asthma, arthritis,
hepatitis or diabetes of a particular variety
are considered as one entity and the cases
are divided into two groups by randomization
procedures. One group is given the
standard drug and one the new drug.
While this concept and methodology is
appropriate for synthetic drugs, it need not
always be appropriate for herbal medicines
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