| CTRI Number |
CTRI/2020/05/025488 [Registered on: 31/05/2020] Trial Registered Prospectively |
| Last Modified On: |
28/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on Guduchi Ghana Vati as a preventive remedy in pandemic of COVID-19 |
|
Scientific Title of Study
|
An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study to Evaluate Safety and Efficacy of Guduchi Ghana Vati as a Preventive Remedy on Healthy Individuals in Pandemic of COVID-19 |
| Trial Acronym |
GGVC19 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIA-CVD-19/2020/01 Version 1.0 Dated 20th May 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Sanjeev Sharma |
| Designation |
Director |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (RAJASTHAN) INDIA
Jaipur
RAJASTHAN
302002
India |
| Phone |
09418079691 |
| Fax |
|
| Email |
profsanjeevhp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PawanKumar Godatwar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan Jaipur, RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
gpawankumar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PawanKumar Godatwar |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan Jaipur, RAJASTHAN
Jaipur
RAJASTHAN
302002
India |
| Phone |
9314502834 |
| Fax |
|
| Email |
gpawankumar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (RAJASTHAN) INDIA |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR - 302002 (RAJASTHAN) INDIA
|
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Dr Sanjeev Sharma |
National Institute of Ayurveda |
OPD No 1, Department of Shalya Tantra, Ground floor,
Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
JAIPUR - 302002 (RAJASTHAN) INDIA
Jaipur
RAJASTHAN |
09418079691
profsanjeevhp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda Madhav Vilas Palace, Amer Road, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi Ghana Vati |
Each Guduchi Ghana Vati contains Guduchi Ghana (Tinospora cordifolia) 500 mg with preservatives and excipients
Dosage and Treatment Duration:
2 tablets twice daily orally after meals with water for 45 days
|
| Comparator Agent |
NIL |
Dosage and Treatment Duration: Subjects in this group will not be given any medicine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, Male or Female subjects between the age group of 18 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring or treatment.
2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating females
2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study
3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy
6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study.
7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 days |
(day-5, day 0, day-15, day-30, day-45) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of incidence of other non COVID-19 infections in both the groups
2. Comparative assessment of severity of COVID-19 in both the groups.
3. Comparative assessment of number of subjects requiring hospitalization, number of days of hospitalization, ICU admission, Ventilator support and mortality rate.
4. Global assessment of overall change as per the investigator
5. Safety assessment by evaluation of occurrence of AE/SAE
|
(day-5, day 0, day-15, day-30, day-45) |
|
|
Target Sample Size
|
Total Sample Size="12000"
Sample Size from India="12000"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/06/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It
is an open label, multi centric, randomized, comparative,
prospective, interventional community based clinical study to evaluate safety
and efficacy of Guduchi Ghana Vati as a preventive remedy on healthy individuals
in pandemic of COVID-19. The trial will be
completed in 12000 subjects in 6 centers across India. Subjects from
group A will be given Guduchi Ghana Vati in a dose of two tablets twice daily
orally after meals with water for 45 days. Subjects from group B will not be
given any intervention. The primary objectives of the study will be comparative
assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and
those not taking it over a period of 45 days. Secondary objectives will be comparative
assessment of incidence of other non COVID-19 infections in subjects taking
GUDUCHI GHANA VATI and those not taking it over a period of 45 days, comparative
assessment of severity of COVID-19 (when it occurs) in subjects taking GUDUCHI
GHANA VATI and those not taking it. Severity will be graded as per the attached
ordinal scale for clinical improvement of COVID-19 published by WHO, comparative
assessment of number of subjects requiring hospitalization, number of days of
hospitalization, number of subjects requiring ICU admission and number of
subjects requiring Ventilator support and mortality rate, global assessment of
overall change as per the investigator and safety assessment by evaluation of
occurrence of AE/SAE on day-5, day 0, day-15, day-30 and day-45. |