This is a topic I researched and presented at work.

1. Clinical Trial Research In
Ayurveda
Introduction to Ayurveda
Need for Clinical Trial Research in Ayurveda
Status of Clinical Trial Research
Problems associated with conducting clinical trials of Ayurvedic
medicines

2. Introduction:
Ayurveda is a comprehensive system of medicine that originated in India. The term "Ayurveda" is a
combination of two sanskrit words "Ayu" meaning life and "Veda" meaning science, which
translates to "Science of Life".
It is the oldest system of medicine which is said to be more than 5000 years old. It has evolved
through thousands of years and is still a very popular choice of medicine in India.
The treatments are given in the form of Herbs, specialized diets, physical therapy and surgeries.

3. Principles:
According to ayurveda the universe is made up of 5 elements known as "Panchamahabhutas".
• Prithvi (Earth)
• Aapa/Jala (Water)
• Teja/Agni (Fire)
• Vayu (Air)
• Aakasha (Vaccum/void)
In the body, these elements combine to form the "tridoshas": Vata, Pitta and Kapha. The word dosha
means impurity or Imbalance.
Health is maintained when theses doshas are in harmony with each other. Any imbalance leads to
development of disease in the body.

4. Diagnosis:
In the diagnosis of a disease, examination of the pulse is considered to be very important. Systemic
examination is also done, which includes examining the tongue, eyes, urine and faces, etc.
Treatment:
The treatment in Ayurveda is individualized. It will be based on the diagnosis of disease and other
factors such as age, sex, temperature, sleep/rest, work pattern and diet.
The main principle of the treatment in Ayurveda is discontinuity of pathogenesis by identifying the
cause and related factors involved in the etiopathogenesis of the disease and accordingly planned
treatment.
Treatment is also based on the psychosomatic constitution (Prakriti) of a patient. Prakriti is defined
as the biological constitution or genetic make up of a person which remains constant throughout
one's life.

5. The treatment is given a holistic approach, it aims to improve not only a person's health, but also their
well being, behaviour and state of mind. It is done by treating the disease and also making lifestyle
changes.
Types of treatments:
Shodhana Karma/Panchakarma (purification and detoxification treatment): cleansing of toxins;
physical or emotional.
Shamana Karma (Palliative treatment): to reduce the intensity of the disease and balance the
doshas.
Rasyana Karma (rejuvenation therapy): to maintain health and reduce the negative effects of the
disease.

6. • Types of ayurvedic formulations:
• Solid/tablet dosage forms: Vatika,
Gutika
• Semi-solid dosage forms: Kalka, Avleha, Paka,
Lepa
• Liquid dosage forms: Swarasa, Kasaya, Taila,
Sura, Asava
• Powder dosage forms: Churna, Bhasma,
Satva, Kshara, Pisti, Arka

7. Need for Clinical Trial Research in Ayurveda:
During the past decades, public interest in natural therapies, namely herbal medicine, has increased
dramatically not only in developing countries but also in industrialized countries.
The demand for Ayurvedic medicine is increasing in countries like Russia, USA, Canada and many
European countries.
Several important factors have contributed to the growth of this worldwide phytotherapeutic
market, among which some of the following may be mentioned below:
 Concern regarding undesirable side effects of modern medicines and the belief that herbal drugs
are free from side effects, since millions of people all over the world have been using herbal
medicines for thousands of years.
 Preference of consumers for natural therapies

8.  High cost of synthetic medicines
 Improvement in quality, proof of efficacy and safety of herbal medicines
 Some conventional therapies, where treatment paradigm is quite slow, psychologically patient
finds solace in herbals
 The holistic approach is more beneficial in patients with conditions associated with chronic pain
(back and neck injuries, arthritis and rheumatism) or illnesses such as cancer whereas orthodox
medicine deals primarily with treating the symptoms
 The popularity of complementary medicine has also been supported by the research efforts into
their safety and effectiveness, although a lack of scientifically valid research into
complementary medicine has always been a significant barrier to orthodox medicine in
accepting these health care approaches

9. The world’s growing fascination with natural remedies, traditional and alternative medicines and
herbs augurs well for India. These can provide a substantial source of income for farmers and
companies across the country. A very small quantity of herbal medicines produced in India is
exported, as they do not meet the regulatory standards required by importing countries.
Currently Ayurvedic medicine is extensively practiced in India although there’s very little quality
control or trials. Approximately two-thirds of India’s rural people, who comprise 70 percent of the
population, use traditional medicine for their primary health care needs.
Modern Indian society recognizes Ayurveda as a legitimate medical system. Practitioners receive
state-licensed, institutionalized medical training. It is estimated that there are over 700,000
registered practicing vaidyas in India (with BAMS or MD Ayurveda qualification).
The prescription of medicines is mainly based on the practitioner’s knowledge and experience.
The problem is that the use of herbals on the basis of experience only by a traditional practitioner
does not assure safety, hence when these herbs are used in high doses and in concentrated form
over a longer duration of period without medical guidance, may cause serious undesirable effects.

10. Although Ayurveda is known to have very less side effects, there have been many reports of severe
and toxic effects which may have been caused by inaccurate preparation of medicines and poor
quality control.
Recently with use of Ayurvedic medicines Lead toxicity has been reported, which might result in
conditions like status epilepticus, fetal developmental delay, etc.
These problems are arising since, there is lack of common standards and appropriate methods for
evaluating Traditional Medicine to ensure the safety, efficacy and quality control.
The patients of the present time are becoming more health conscious and they understand the
concept of clinical research for evaluation of efficacy and safety of medicines. People are trusting
medicines with more scientific proof of effectiveness.
Therefore, it is important to evaluate the safety and effectiveness of Ayurvedic drugs and other
therapies in humans and there is no other way than through clinical trials to assess safety of herbal
medicine and, for proof of efficacy.
Clinical trials can show researchers what does and doesn’t work in humans that cannot be learned
in the laboratory or in animals and documenting these trials in the form of publications will help in
improving the quality of treatment provided.

11. In India, as of now, clinical trials are not mandatory for acquiring licenses for patented or
proprietary Ayurvedic, Siddha and Unani (ASU) drugs, whereas in allopathic drugs clinical trials are
a necessary part in obtaining a marketing license from Central Drugs Standard Control Organization
(CDSCO).
ASU drugs are regulated by the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha
and Homoeopathy) which has stated that the term ‘clinical trial’ is not mentioned in provisions of
the Drug and Cosmetic Act with reference to ASU drugs.
However, as a regulatory requirement, evidence regarding efficacy for the ASU drug needs to be
supported by textual rationale, published literature and/or pilot study.
Ayurvedic Drug Manufacturers Association opposed the initiation of clinical trials with ASU drugs as
it may have detrimental effect on the growth and prosperity of ASU drug industry.
They argued that ASU drug industry is a small player as compared to million-dollar conventional
pharmaceutical industry and carrying out clinical trials in case of ASU drugs cannot be viable as well
as economical.

12. Status of Clinical Trial Research in Ayurveda:
At present, our country is having a full-fledged Central Council for Research in Ayurveda System
(CCRAS) with sufficient financial support and ample task force for research and is contributing its
share in Ayurveda field.
The Council has been executing its research programmes with a network of 30 peripheral
Institutes/centres/units with the headquarters office responsible for control, monitoring and
supervision.
• Validation and development of formulations for disease/clinical conditions such as obesity,
cardiovascular disease, malaria, mental retardation, epilepsy, osteoarthritis and diabetes etc.
• Steps have been taken to develop a Standardized Questionnaire for Assessment of Prakriti
• Further, the Council has been conducting clinical research in collaboration with reputed
institutes in certain disease conditions/areas such as improving quality of life in cancer patients,
Mental Retardation, geriatric health.
• Pharmacological studies of about 400 Ayurvedic drugs/formulations & safety/toxicity study of
more than 50 Ayurvedic drugs/formulations have been conducted.

13. In addition, there are many institutes of the country where postgraduate courses in Ayurveda are
being conducted leading to MD/MS (Ayu.) and PhD degrees. Research is a mandatory part of these
degrees; thus, these institutes are contributing as a resource for research in various specialties of
Ayurveda. Also, majority of the clinical trials are being conducted in these institutes.
However, difficulty is that these courses are time bound and the research scholars have to
complete their work within the stipulated period of 2 years or so; therefore, long-time clinical
studies are not possible in these centers.
Majority of the clinical trials are being conducted for academic purposes and there's less trials
conducted to study the safety and efficacy of a particular product.
Some companies such as the Himalaya Drug company are conducting clinical trials, for their drugs.
For example, they have conducted clinical trials on many of their products such as, Liv.52, Mentat,
Septilin, etc, but only some of these studies and findings get published in peer reviewed journals,
the rest are quoted on literature of firm or the flip charts while explaining to doctors.

14. There are many reasons as to why many of the Ayurvedic Drug manufacturers don't consider
conducting clinical trials.
One reason is that they are much more expensive and there are many other difficulties in
conducting clinical trials on Ayurvedic formulations.
The main reason given is that the medicines are natural, household items which have been used
in India for centuries and have been considered safe with no side effects. They are documented
for their use, tested over the years for effects/side effects and improved upon.
Whereas the allopathic drugs are often entirely new, synthesized products, hence they need
clinical trials for studying efficacy, long term effects, side effects etc.
So, they believe that Ayurvedic medicines don't need to go through clinical trials. The
Government and regulatory bodies have also considered them as safe to use.
Therefore, there is not enough importance given to clinical trial research in Ayurveda. Also, the
trials which are being conducted are being said to be of inadequate quality.

15. According to a study of the CTRI registry conducted by 2 professors of Fiji National University in
2015, the quality of clinical trials was found to be substandard.
In the study, search was made with the key word “Ayurveda” and all obtained clinical trials were
studied (2012 to 2015). They found many issues such as:
• Although majority of the trials were randomized, double blinded and single centered, still not all
of them had mentioned the nature of randomization and allocation concealment.
• Majority of the studies were conducted for academic purposes. Considerable numbers of trials
were conducted on patients with unclear phase and rarely were they published.
A very recent example of clinical trials in Ayurveda which was in the news was involving the
"Coronil" tablet, which is manufactured by Patanjali Ayurveda Ltd. It consists of three herbs:
Ashwagandha, Giloy, and Tulsi.
The license was acquired for the drug as an immune booster and for treating cough and fever but,
the drug was later advertised as a cure for COVID-19 and launched as a part of the "Corona Kit" in
June 2020.
This caused controversy as people questioned the authenticity of the product, and the IMA
opposed the product strongly saying Coronil does not have the sanction of the World Health
Organisation (WHO) and asked for proof of the efficacy of the drug.

16. Patanjali claimed to have conducted a double-blinded, placebo-controlled clinical trial.
Ministry of AYUSH asked for submitting the trial papers, including Institutional Ethics Committee
clearance, CTRI registration and results data of the study. It also asked the company to stop
advertising/publicizing such claims till the issue was examined.
According to research papers submitted to AYUSH Ministry, the clinical trials were conducted only
on 120 asymptomatic, mildly symptomatic and moderately symptomatic patients between the 15
to 80 years age group. The drug was not tested, on any severe coronavirus patients.
Patanjali claimed that 69% of the patients showed recovery on Day 3 PCR tests and 100%
recovery on test conducted on the 7th day, which was 35% better recovery than the patient
group on placebo.
And after examining the study, the license was updated for Coronil tablet to be used as
supporting measure in the management of COVID-19 without claiming as a cure, as it failed to
prove the efficacy.

17. Problems Associated with Conducting Clinical Trials in Ayurveda:
Conducting clinical trials on traditional/herbal medicines is quite challenging due to lot of
reasons, for instance:
• It is very difficult, impracticable or sometimes impossible to have active and control groups
with identical color, smell and taste. Also, the use of placebo involves similar difficulties as the
herbal study drug may exhibit its strong aroma, a specific distinguished taste and hence these
cannot be exactly imitated while manufacturing a placebo.
• The problems are multiplied when working with formulations containing more than one plant
extracts. Special attention must also be paid on standardization of the compounds.
• There are difficulties in estimation of ‘active’ molecules in body fluids in the pharmacokinetic
studies in phase I.
• Storage conditions can also alter the bioavailability of herbal medicines.
• The system of herbal medicine advocates the choice of herbs, compounding or mixtures,
dosage and duration so that it suits the particular psychosomatic constitution (Prakriti) of the
patient. Therefore, administration of a study drug to a subject population of various
constitutions may not yield uniform outcomes.

18. • Selection of dosage regimen may also pose problems. Dose must be calculated on the basis that
whether crude drug or extract is used.
• Many a times the medicine system advocates other procedures along with oral therapy which
again may or may not be standardized. Also, there is no standard single benchmark formulation,
especially if a single drug therapy is concerned for various therapeutic areas, as they are present
in modern medical science.
• Other reasons include the fact that integrated approach of many herbal systems does not
differentiate the disease from the patient since the treatment is supposed to be individualized.
This approach creates difficulties for the inclusion and exclusion criteria in clinical trial.
• Also, Ayurveda proposes different interventions at different stages of disease in the same patient
providing another difficult to control variable in a clinical trial. Diet component may also affect
the treatment outcome in clinical trial.
• The issues associated with safety and quality of herbal medicines include toxic herbs,
contamination with heavy metals, microbial organisms, and other contaminants (such as
pesticides) as well as deliberate combination (adulteration) with pharmaceutical products.

19. • The problem with the use of herbal medicines is the fact that it is not always clear whether
interactions exist between herbal medicine and other medicinal products or substances like
alcohol, caffeine, tobacco or nicotine or with diet. Some of the common herb-drug interactions
includes:
a) Bleeding- when warfarin is combined with Ginkgo biloba, garlic, dong quai or danshen
b) Serotonin syndrome- when St. Johns' wort is combined with serotonin-reuptake inhibitors
c) Induction of mania in depressed patients - when antidepressants are mixed with Panax
ginseng
• Another problem with research on alternative medicine is the fact that complementary health
practitioners often question the suitability of randomized clinical trials in relation to
complementary medicine because of the holistic approach (ie, treating mind, body and soul at
the same time) that is required and the fact that the alternative medicine is normally tailored
specifically for each individual.
• Practitioners suggest it is inappropriate to test only one treatment in isolation and to give it to
all participants in the same manner and amount, as occurs in randomized clinical trials.
As a function of such difficulties, few herbal drugs have been studied adequately but well-
controlled, double-blind clinical trials to prove their safety and efficacy have been lacking.

20. Conclusion:
Due to various reasons as mentioned earlier, clinical trial research is not being given enough
importance in case of Ayurvedic drugs and formulations. Only few clinical trials are being conducted
and more focus has to be on the quality of studies to generate high quality of evidence for drugs.
Developing standardized methods to study the holistic approach treatment more effectively is
important. Also, further research is required to overcome the problems associated clinical trials of
herbal medicines.
Now, there is a fully-fledged council (CCRAS) in India to support the research in Ayurveda. They
should encourage conducting clinical trials for generating high quality data for efficacy and safety of
formulations.

21. References:
• Research In Ayurveda - http://www.ccras.nic.in/content/research-Ayurveda
• Clinical trials in Ayurveda: Analysis of clinical trial registry of India -
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5052373/
• No Clinical Trials Need For Ayurveda, Unani, Siddha Medicines: Government Of India -
https://business.medicaldialogues.in/no-clinical-trials-need-for-ayurveda-unani-siddha-medicines-government-
of-india?infinitescroll=1
• Problems associated with clinical trials of Ayurvedic medicines -
https://www.scielo.br/j/rbfar/a/rjVhRWbrhCdRVnYhqBhFtwp/?lang=en
• AYUSH clarification on clinical trial for license of ASU drugs -
http://pharmabiz.com/NewsDetails.aspx?aid=110177&sid=9
• Ayurveda: (W)here is the evidence - https://www.sciencedirect.com/science/article/pii/S0975947620300590
• Clinical trials in Ayurveda: Issues, challenges and approaches -
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5954257/