| CTRI Number |
CTRI/2020/05/025276 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
21/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
effect of Ayurvedic intervention in COVID-19 positive cases |
|
Scientific Title of Study
|
A Pilot study to estimate the effectiveness of Ayurvedic intervention in COVID-19 positive cases |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Arun Gupta |
| Address |
CBPACS, Khera Dabar, New Delhi 110073
Department of Panchakarma
Khera Dabar
New Delhi
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Arun Gupta |
| Address |
CBPACS, Khera Dabar, New Delhi 110073
Room no 142
department of Panchakarma
CBPACS
New Delhi
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Arun Gupta |
| Address |
CBPACS, Khera Dabar, New Delhi 110073
Room no 142
Panchakarma Department
CBPACS
New Delhi 110073
South West
DELHI
110073
India |
| Phone |
9999155377 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Ch Brahm Prakash Ayurved Charak Sansthan
Autonomous body under GNCTD
Khera Dabar
New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najafgarh, New Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| ProfDr Vidula Gujjarwar |
Ch. Brahm Prakash Ayurved Charak Sansthan |
Hospital section
Khera Dabar,
New Delhi 110073
South West
|
9990174348
cbpayurved@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ch. Brahm Prakash Ayurved Charak Sansthan, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Coronavirus as the cause of diseases classified elsewhere |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Ayurveda Protocol |
1. Sanshamani Vati (Tinospora cordifolia) 1gm BD with 50ml Nagaradi kwath(Decoction of Zingiber officinale -2 part, Terminalia chebula- 4 part, Tinospora cordifolia-6 part in quantity) 2.Amalaki Churna ( Powder of Phyllanthus emblica)3gm with water once a day at 5pm 3.Golden Milk (100ml of milk with 3gm of Curcuma longa) at 9pm.
all to be taken orally
Duration 14 days |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Willingness to participate in the study and provide the informed consent.
2. Isolated asymptomatic cases that have been tested positive for SARS-CoV2 virus.
|
|
| ExclusionCriteria |
| Details |
1. Cases presenting with severe symptoms of COVID-19.
2. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Time taken and number of patients progressing from asymptomatic to symptomatic condition.
|
baseline
Daily
14 days |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Time taken to negative conversion of RT-PCR
|
Baseline
10th day
15th day
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
Brief Summary
Modification(s)
|
Chaudhary Brahm Prakash Ayurved Charak Sansthan (Ayurveda) which is an ISO certified Ayurveda institute is designated as COVID-19 health care center (CHC) on 16.04.2020 vide order no.F.No.PA/SS-II/2020/H&FWSS3hfw/47. In this CHC 111 beds are dedicated for managing COVID-19 positive cases up to moderate symptoms. COVID-19 positive cases are referred by government approved COVID-19 testing Centre (CTC) for isolation at Ayurveda. If patients develop any severe symptoms they are transferred by dedicated ambulance to Lok Nayak Jai Prakash Narayan hospital which is attached as COVID-19 treatment centre. This research is aimed to explore the possibility of preventing COVID-19 patients from going to progressive stages of the diseases by using Ayurveda intervention Ayurveda Treatment protocol includes Sanshamani vati (AFI part 1, 10/13), Nagaradi kwath (AFI part 1, 4/1), Amalaki churna (API part 1) and Golden milk (milk+ turmeric) which is used to improve the status of Agni and enhancing strength of the patient. These drugs possess antiviral, antimicrobial and immune modulator properties |
