CTRI Number |
CTRI/2020/05/025273 [Registered on: 20/05/2020] Trial Registered Prospectively |
Last Modified On: |
17/03/2021 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
Impact of effect of Ayurvedic treatment on novel Corona virus disease |
Scientific Title of Study
|
Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) |
Secondary IDs if Any
|
Secondary ID |
Registry |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Ganpat Devpura |
Address |
Professor Department of Medicine
National Institute of Medical Sciences and Research, Jaipur
India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 303121 India |
Phone |
9829069669 |
Fax |
|
Email |
gdevpura@yahoo.co.in |
|
Details Contact Person Scientific Query
Modification(s)
|
Name |
Dr Abhishek Sharma |
Address |
Professor Department of Medicine
National Institute of Medical Sciences and Research, Jaipur
India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 302021 India |
Phone |
9828816135 |
Fax |
|
Email |
dr.abhisheksharma1987@gmail.com |
|
Details Contact Person Public Query
Modification(s)
|
Name |
Dr Abhishek Sharma |
Address |
Professor Department of Medicine
National Institute of Medical Sciences and Research, Jaipur
India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India Jaipur RAJASTHAN 302021 India |
Phone |
9828816135 |
Fax |
|
Email |
dr.abhisheksharma1987@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
Patanjali Research Institute
Governed by Patanjali Reserach Foundation Trust, Haridwar, Uttrakhand |
|
Primary Sponsor
|
Name |
Patanjali Research Institute |
Address |
Patanjali Research Institute Patanjali Yogpeeth Trust Haridwar, Uttarakhand |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
Name |
Address |
National Institute of Medical Sciences Jaipur |
NH 11 C Jaipur Delhi Highway, Nims University Campus, Jaipur, Rajasthan, India |
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 1 |
Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
Deepak Nathiya |
National Institute of Medical Sciences |
Department of Medicine, National Institute of Medical Sciences & Research, Nims University Rajasthan, Jaipur NH 11 C Jaipur Delhi Highway Nims University Campus, Jaipur, Rajasthan, India Jaipur |
9929600137
deepaknathiya@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Respiratory failure, unspecified |
|
Intervention / Comparator Agent
Modification(s)
|
Type |
Name |
Details |
Intervention |
Ayurvedic Therapy |
Tablet Pure Ashwagandha 500mg BD, Oral, After Breakfast / Dinner
Tablet Pure Giloy Extract 1000 mg BD, Oral, after Breakfast / Dinner
Tablet Pure Tulsi Extract 500 mg BD, Oral, after Breakfast/Dinner
Anu Taila 4 drops BD, Nasal Drop
Powder Swasari Ras 2 gm BD, Oral, Before Breakfast / Dinner |
Comparator Agent |
Placebo Therapy |
Placebo of same dosage form by Oral / Nasal route |
|
Inclusion Criteria
|
Age From |
15.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Asymptomatic patients
Mildly symptomatic patients
Moderately symptomatic patients
Age 15-80 years of age
Patients able to give Informed consent and follow instructions
Agree to follow at 14 days and 30 days after testing positive for COVID-19 |
|
ExclusionCriteria |
Details |
Severely symptomatic patients (SaO2 <90%)
Acute Respiratory Distress Syndrome (ARDS)
Life expectancy less than 1 year due to other co-morbid conditions |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
|
Blinding/Masking
|
|
Primary Outcome
|
Outcome |
TimePoints |
Virological Clearance as measured by RT PCR of nasopharyngeal swab |
Baseline, 3 Days, 7 Days, 14 Days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Conversion from Symptomatic to Asymptomatic patient
Reduction in C-reactive protein, ESR & IL-6
Improvement in heamatological parameters eg Total Leucocyte count
Safety analysis |
Baseline, 3 Days, 7 Days, 14 Days |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
29/05/2020 |
Date of First Enrollment (Global) |
No Date Specified |
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Phytomedicine Volume 84 April 2021 153494 |
Brief Summary
Modification(s)
|
COVID-19 infection is known to affect individuals with weak immunity more severely. Therefore, enhancing immunity is definitely one of the ways the doctors across the globe have been using for treating COVID-19 cases. The study is Interventional Randomized parallel group placebo controlled, Single Centric trial in which Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) will be accessed. To combat COVID-19 virus with Ayurveda, we have screened close to 1000 phytochemicals from more than 100 medicinal plants, in-sillico. We looked for their binding affinities to COVID-19 essential proteins and host protein interactions. We have discovered that natural phytochemicals in Ashwagandha, Giloy and Tulsi indeed have potentials to combat COVID-19 and its pathogenicity. The patients who will be included in the study’s active control group will receive - Tablet Swasari Ras : (500 mg) Tablet Pure Ashwagandha Extract : (500 mg) Tablet Pure Giloy Extract : (500 mg) Tablet Pure Tulsi Extract : (500 mg) Anu Taila (Nasal drop) The above mentioned ayurvedic medicines will be used at following dosage : In the morning: At-least 60 mins before break-fast : 4 drops of Anu Taila (Nasal drop), in each nostril. At-least 30 mins before break-fast : Swasari Ras 2 gm (with luke-warm water) At-least 30 mins after break-fast : 2 Tablets Pure Giloy Extract 1 Tablet Pure Ashwagandha 1 Tablet Pure Tulsi Extract (with luke-warm water) In the evening: At-least 30 mins before dinner : Swasari Ras 2 gm (with luke-warm water) At-least 30 mins after dinner : 2 Tablets Pure Giloy Extract : 1 Tablet Pure Ashwagandha 1 Tablet Pure Tulsi Extract (with luke-warm water) The above mentioned active control group will be compared with Placebo group receiving placebo of same dosage form. Symptomatic treatment will follow in both group along with treatment. The primary outcome of the study will be assessed by measuring virological clearance as measured by RT PCR for nasopharageal swab at baseline, 3rdday, 7thdays and 14th day. The secondary outcomes will be assessed by measuring conversion from symptomatic to asymptomatic patient, reduction in CRP protein, ESR & IL-6. Further improvement in hematological parameter, Total leucocyte count and lymphocyte count. Safety analysis will also be done. |