| CTRI Number |
CTRI/2020/06/026197 [Registered on: 28/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2022 |
| 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
|
Validation of Classical Ayurvedic formulations in treatment of COVID-19 |
|
Scientific Title of Study
|
To Evaluate the Efficacy of SUDARSHAN GHAN VATI and VYAGHRADI KWATH in the management of patients with COVID-19- A Pilot study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amanpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Department of Indian Systems of Medicine, J&K, Jammu |
| Address |
127/3, Trikuta Nagar, Jammu
Department of Shalyatantra, Government Ayurvedic Medical College
Indira Chowk,
Jammu
Jammu
JAMMU & KASHMIR
180012
India |
| Phone |
9811933102 |
| Fax |
|
| Email |
contactdramanpreet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amanpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Department of Indian Systems of Medicine, J&K, Jammu |
| Address |
127/3, Trikuta Nagar, Jammu
Department of Shalyatantra, Government Ayurvedic Medical College
Indira Chowk,
Jammu
Jammu
JAMMU & KASHMIR
180012
India |
| Phone |
9811933102 |
| Fax |
|
| Email |
contactdramanpreet@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amanpreet Kaur |
| Designation |
Assistant Professor |
| Affiliation |
Department of Indian Systems of Medicine, J&K, Jammu |
| Address |
127/3, Trikuta Nagar, Jammu
Department of Shalyatantra, Government Ayurvedic Medical College
Indira Chowk,
Jammu
Jammu
JAMMU & KASHMIR
180012
India |
| Phone |
9811933102 |
| Fax |
|
| Email |
contactdramanpreet@gmail.com |
|
|
Source of Monetary or Material Support
|
| Extra Mural Research scheme of Ministry of AYUSH
2nd floor,Office block no. 3
NBCC office complex,
Kidwai nagar,
New Delhi-23 |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH GoI |
| Address |
2nd floor
office block no 3, NBCC office complex
Kidwai Nagar
New Delhi-23 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amanpreet Kaur |
Goverment Medical College, Jammu |
Goverment Medical College, Bakshi Nagar, Jammu
Jammu
JAMMU & KASHMIR |
9811933102
contactdramanpreet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RARIUD (CCRAS), JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z208||Contact with and (suspected) exposure to other communicable diseases, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (3) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional treatment for covid 19 |
Conventional treatment for covid 19 |
| Intervention |
Sudarshan Ghanvati and Vyaghradi Kwath |
Sudarshan Ghanvati 500 mg Tablet 2 TDS, Orally
Vyaghradi Kwath 60 ml BD, Orally
Duration- For 30 days.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of COVID-19 positive cases with mild to moderate symptoms
2. Patients who can take medicine orally
3. Patients willing to provide signed informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe symptom
2. Immuno compromised patients
3. Pregnant / Lactating females
4. COVID-19 negative patients
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in duration of conversion from COVID positive to negative |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of Life |
30 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/07/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The world is witnessing Global Pandemic COVID -19. The lack of approved effective drug therapeutic protocol for COVID-19 would be a challenge for the treatment of the newly merged COVID -19 infections world wide. Ayurveda medicine is already being used in many states to prevent and cure the disease. Aim of this proposal is to evaluate the efficacy of Sudarshan Ghan Vati and Vyaghradi Kwath in the management of mild to moderate symptoms of COVID-19 positive patients. The trial will be conducted at Government Ayurvedic Hospital, Department of ISM&H, Government of J&K, Indira Chowk, Jammu, Government Medical College, Bakshi Nagar, Jammu and 200 bedded (Maternity) designated COVID hospital, Gandhi Nagar, GMC, Jammu. This study will be collaborative with duration of three months. The subjects will be randomly divided in two groups: Conventional treatment group and Ayurvedic & Conventional group. Sample size would be 60 and intervention time will be one month. Ethical clearance and consent is already taken. Laboratory investigations , assessment and follow up will be done as per methodology. Financial burden can be reduced if the result is found positive. |