| CTRI Number |
CTRI/2020/05/025213 [Registered on: 15/05/2020] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda formulation for COVID-19 prevention |
|
Scientific Title of Study
|
Impact of Ayurvedic intervention (Guduchighan vati)in prevention of COVID-19 infection in containment areas of Himachal Pradesh-A community based study |
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 Kavita Vyas |
| Address |
Regional Ayurveda research institute for nutritional disorders, Ground floor, Room number 3 Jaral Pandoh
Near BBMB Hospital
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
8219339718 |
| Fax |
|
| Email |
kavitakrishu@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Kavita Vyas |
| Address |
Ground floor Room number 3 Regional Ayurveda research institute for nutritional disorders Jaral Pandoh District Mandi
NEAR BBMB HOSPITAL
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
8219339718 |
| Fax |
|
| Email |
kavitakrishu@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Kavita Vyas |
| Address |
Ground floor Room number 3 Regional Ayurveda research institute for nutritional disorders Jaral Pandoh District Mandi
Mandi
HIMACHAL PRADESH
175124
India |
| Phone |
8219339718 |
| Fax |
|
| Email |
kavitakrishu@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Central Council for research in Ayurvedic Sciences |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Central Council for Research in Ayurvedic Sciences
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India ) |
| Type of Sponsor |
Other [research organisation ] |
|
|
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 |
| Dr Kavita Vyas |
Regional Ayurveda research institute for Nutritional Disorders |
Department of central council for research in Ayurvedic Sciences, Jaral Pandoh 175124
Mandi
|
9888552911
kavitakrishu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RARIND IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of COVID-19 in containment zones |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi ghan vati |
drug to be given in dose of 500mg BD with lukewarm water before meals for 30 days |
| Comparator Agent |
Not applicable |
not applicable |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Residents of the identified containment zones, marked by government of Himachal Pradesh for high risk of COVID 19
Willing to take study medication,
Provides written informed consent prior to initiation of study Procedures.
|
|
| ExclusionCriteria |
| Details |
Persons already treated with study drug during the last 30 days;
Pregnant and lactating females and those who have a pregnancy plan.
Participants with any immunosuppressive medication or in an immune Compromised state or hematological disease.
Laboratory confirmed COVID-19 cases with or without symptoms.
Known allergy to the medication used in this trial.
Not willing to participate in the study.
Any other criteria, as per the investigator would jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Incidence of COVID 19 positive cases as confirmed by hospital by standard investigation, real time polymerase chain reaction test among Ayurveda users. |
At baseline,1 week, 2 weeks, 3 weeks, 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Incidence of severe COVID 19 positive cases (admitted in hospital and requiring ventilation and/or multi-organ failure as reported by hospital) among Ayurveda users.
2) Incidence of mortality due to COVID 19 among Ayurveda users as compared to non-users.
3) Incidence of any other ailment like cough, fever, sore throat etc. (as per questionnaire annexed) during this study.
4) Change in appetite, bowel habit, sleep among the users
|
7th, 14th, 22nd and 30th day after first visit |
|
|
Target Sample Size
|
Total Sample Size="1500"
Sample Size from India="1500" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Outcomes of the study will be published in the reputed journal of the council, Journal of Research in Ayurvedic Sciences JRAS |
|
Brief Summary
|
| Ministry of AYUSH has released certain guidelines for prevention of COVID through certain common kitchen spices, herbs and practices. In order to capture the effectiveness of such preventive measures, guidelines and Ayurveda advocacies, a prospective intervention community study is planned to capture the relative risk and incidence of COVID 19 among Ayurveda users. The study will be conducted as an open label prospective community-based study. It is designed to capture the desired objectives of the study, based on pre-defined close ended and certain open-ended questions to collect the data. | |
