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CTRI Number  CTRI/2020/05/025332 [Registered on: 23/05/2020] Trial Registered Prospectively
Last Modified On: 20/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Ashwagandha for prevention against SARS-CoV-2 Infection: A Randomized Hydroxychloroquine Controlled drug trial in high risk Health Care Providers 
Scientific Title of Study
Modification(s)  
Ashwagandha for the Prophylaxis against SARS-CoV-2 Infection: A Randomized Hydroxychloroquine Controlled Clinical Trial in Health Care Providers 
Secondary IDs if Any  
Secondary ID  Registry 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR ARVIND CHOPRA 
Address  11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE
11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE 411001 MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  91-20-26344099  
Fax  91-20-26350084  
Email  crdp5624@gmail.com  
 
Details Contact Person
Scientific Query
 
Name  DR ARVIND CHOPRA 
Address  11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE
11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE 411001 MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  91-20-26344099  
Fax  91-20-26350084  
Email  crdp5624@gmail.com  
 
Details Contact Person
Public Query
 
Name  DR ARVIND CHOPRA 
Address  11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE
11 HERMES ELEGANCE 1988 CONVENT STREET CAMP PUNE 411001 MAHARASHTRA
Pune
MAHARASHTRA
411001
India 
Phone  91-20-26344099  
Fax  91-20-26350084  
Email  crdp5624@gmail.com  
 
Source of Monetary or Material Support  
MINISTRY OF AYUSH 
 
Primary Sponsor  
Name  MINISTRY OF AYUSH  
Address  AYUSH BHAWAN, GPO COMPLEX, NEW DELHI 110023 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
COUNCIL OF SCIENTIFIC AND INDUSTRIAL RESEARCH   ANUSANDHAN BHAWAN, 2 RAFI MARG, NEW DELHI 110001 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaya Chakravarty  Banaras Hindu University  Dept of General Medicine, IMS, Varanasi 221005
Varanasi
 
9453003725

tapadar@gmail.com 
DR ABHAY UPPE  D Y Patil University School of Medicine and Hospital  Nerul, Navi Mumbai 400 706
Mumbai
 
9769319554

abhay.uppe@dypatil.edu 
Dr Dilip Gode  Datta Meghe Institute of Medical Sciences  Nagpur 440022
Nagpur
 
9822737919

dilipgode@yahoo.com 
Dr Deepti Talmohite  ESI Hospital  Akurli Road, Kandivali (East)
Mumbai
 
9869268694

dr.deeptir.talmohite@esic.nic.in 
Vaidya Manohar Gundeti  RRAP Central Ayurveda Research Institute for Cancer CCRAS  Podar Medical Campus, Dr A B Road, Worli, Mumbai, 400018.
Mumbai
 
9004960133

drmanoharccras@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES, INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY, INSTITUTIONAL ETHICS COMMITTEE  Approved 
INSTITUTIONAL ETHICS COMMITTEE, D Y PATIL UNIVERSITY SCHOOL OF MEDICINE  Approved 
Institutional Ethics Committee, Employees State Insurance- Postgraduate Institute of Medical Sciences and Research Model Hospital  Approved 
R R A Podar Central Ayurveda Research Institute for Cancer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  B972 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Ashwagandha (Withania somnifera  Ashwagandha has immunomodulant and immune enhancing activity. It is anti oxidant and promotes health 250 mg, 2 tablets twice a day for 12 weeks 
Comparator Agent  Hydroxychloroquine  HCQ is considered to be anti viral and anti inflammatory. 400 mg tablet. 400 mg tablet twice a day on Day 1, 400 mg once a week for 7 weeks 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  1) Participants of either sex, 20 to 69 years of age.
2)Participants tested negative for COVID-19 by nose throat swab using PCR technique
3) Participants should be naive for HCQ
4) Willing to come for regular follow – up visits
5) Written Informed Consent
 
 
ExclusionCriteria 
Details  1)Individuals with known hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency)
2)Pregnant women, lactating women and women of child bearing potential. hypersensitivity orIntolerance to Hydroxychloroquine will not be assigned to HCQ intervention arms in Group A and Group B
Contraindications to HCQ use such as psoriasis, porphyria, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency

3)Individuals with known allergy or contraindication to Ashwagandha

4) Have any Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the participant at increased risk during the study
5) History of having received any investigational drug in the preceding one month.

6) Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other anti-hitaminic drugs, liquorice and potassium lowering drugs
7) History of taking any kind of Ayurvedic formulation or any other form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months
8) Unwilling to come for regular follow-up for the entire duration of the study.
9)Non – co-operative attitude of the participant
10) Any condition that, in the opinion of the investigator, does not justify the
participant’s inclusion in the study.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
(i)Proportion of SARS-CoV-2 infection free participants on completion of study
(ii)Proportion of participants contracting COVID-19 during the study period
 
WEEK 12 
 
Secondary Outcome  
Outcome  TimePoints 
proportion of participants developing COVID-19, drug related adverse event, drug tolerability, General Health Related Questionnaire (behavior, habit and fitness/ HR-BHF), Quality of life (WHO QOL Brief), Ayurveda measures, Immune Status (serology for specific anti SARS-CoV-2 IgM and IgG antibodies)  week 12 
 
Target Sample Size   Total Sample Size="400"
Sample Size from India="400" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
28/05/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
Not Yet Applicable 
Brief Summary
Modification(s)  
There is an urgent need for effective and safe chemoprophylaxis against Severe Acute Respiratory Syndrome - Corona Virus-2 (SARS-CoV-2). There is no drug or any vaccine available. Several effective non-drug methods of protection are being vigorously followed but still the morbidity and mortality in COVID-19 is striking.  ICMR has issued an advisory on empirical use of Hydroxychloroquine (HCQ) in high risk individuals and thousands of Health care providers (HCP) are following a weekly regiment for seven weeks with utmost caution against drug related toxicity. However, the clinical evidence so far for the anti-viral efficacy of HCQ is sparse and its use is mostly based on in-vitro ex-vivo studies. ICMR has stated that ‘proof of concept and pharmacokinetic studies’ (HCQ) will be required expeditiously. The pandemic is likely to last longer requiring a drug with more prolonged efficacy and better safety. A drug that enhances immunity and has some anti-viral effects may be a good option.

Ashwagandha, ancient well known Ayurveda ‘Rasayana’, is popularly used to build immunity in several medical disorders and has demonstrated unequivocal beneficial effect on the immune cells and system in laboratory experiments for over 3 decades. Clinically, it is shown to be a good immunomodulatory drug in intensely inflammatory autoimmune disorders like rheumatoid arthritis. It is also a potent anabolic and anti-oxidant agent. Of late, it was shown to interfere with the binding of SARS-CoV-2 to the host cell receptor (ACE 2) but this is not yet validated.

Ministry of AYUSH and CSIR GOI has initiated a comprehensive clinical drug trial to study the clinical efficacy and safety of Ashwagandha in the prophylaxis against COVID-19 in HCP. Consenting and eligible HCP will be randomized to either of the two intervention arms- HCQ (standard use as per ICMR advisory) and Ashwagandha (experimental as per Ayurveda expertise) with a caveat that the individual will be permitted to refuse the randomized allocation at baseline and exercise personal choice to switch over to the alternate allocation (Zelen Model of randomization). Further, the design will be that of an open label phase, parallel efficacy multicentre drug trial. The sample size is calculated for an equivalence design (7.5% two sided) with a statistical power of 80% and an alpha significance at two sided p<0.05. With adjustments for withdrawals and a reduction in power due to Zelen model, it is estimated to enrol 200 participants in either arm of the study. While the weekly use of HCQ will stop after 7 weeks (ICMR advisory), the daily use of Ashwangandha will continue till study completion.  The duration of the study for all participants will be 12 weeks with a daily monitoring of COVID-19 symptoms using a mobile app.  Physician centric evaluations will be done by both Ayurvedic and Allopathic physicians at baseline and every 4-week thereafter till study completion. Quality of life and general health will be assessed using suitable questionnaires. Nasal and throat swabs will be collected and tested repeatedly for SARS-CoV-2 RNA using real time RT-PCR along with special assays for selected cytokines and neutralizing antibodies (IgM and IgG). Routine blood tests will be carried out for an overall assessment of health. The primary efficacy measure is the proportion of study participants free of SARS-CoV-2 and COVID-19 on study completion. There are several secondary efficacy measures including pertaining to Ayurveda assessment and safety and tolerability (drug).The drug trial will strictly adhere to the standard guidelines on drug trials (especially human subjects, GCP, adverse event reporting) from Declaration of Helsinki, WHO and ICH  (2017), ICMR (2018) and AYUSH/CCRAS (2018). 


 

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