| CTRI Number |
CTRI/2020/05/025093 [Registered on: 11/05/2020] Trial Registered Prospectively |
| Last Modified On: |
10/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Study of effect of Yashtimadhu tablet for the prevention of COVID -19 on healthy individuals. |
|
Scientific Title of Study
|
Observational Study of YASHTIMADHU TABLET intake as a preventive measure in pandemic of COVID-19 – An open label, Randomized, Controlled, Prospective, interventional, Community-based Cclinical study on healthy subjects
|
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Babu |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
8096455323 |
| Fax |
|
| Email |
narivbd.vijayawada@gmail.com |
|
Details Contact Person
Scientific Query
|
| Name |
Dr G Babu |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
8096455323 |
| Fax |
|
| Email |
narivbd.vijayawada@gmail.com |
|
Details Contact Person
Public Query
|
| Name |
Dr Sujata pundlikrao Dhoke |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
9824744048 |
| Fax |
|
| Email |
sujubasic@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of AYUSH Govt of India |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
Ministry of Ayush , Ayush Bhavan, B Blick GPO complex, INA New Delhi110023 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujata Pundalikrao Dhoke |
Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada |
Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada
Krishna
|
9824744048
sujubasic@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preventive |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Yashtimadhu tablet |
YASHTIMADHU TABLET -250 mg X 2 tablets b.d.
for one month
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
68.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult Male or Female subjects above the age of 18 years to 68 years.
2.Subjects who are from a community where at least 1 confirmed case is already identified.
3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and Lactating females
2.Known cases of uncontrolled Diabetes and Hypertension.
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, 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 1 month prior to screening in the present study.
7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention.
8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care |
15,30 and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of severity of Covid-19 infection in subjects taking YASHTIMADHU TABLET and those not taking it in following situations:
a) Assessment of subjects not requiring hospitalization
b) Severity of symptoms of hospitalized patients in wards
c) Patients requiring ICU admission / Ventilator support
2. Global assessment of overall change as per the investigator (Efficacy assessment)
|
15,30 and 45th day |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200" |
Phase of Trial
Modification(s)
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/05/2020 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
nil |
|
Brief Summary
|
Currently, there are no specific vaccines or treatments for COVID-19.
Evidence is needed on pre-exposure prevention, post-exposure prevention, and
patient management.To address these challenges
and accelerate the research needed in resource-limited settings, we propose
this study to evaluate Ayurveda Intervention as a prophylaxis for COVID-19
infection in healthy adult volunteers with Primary outcome of Comparative assessment of
occurrence of COVID-19 infection in healthy volunteers in community having at
least 1 confirmed case already identified with control arm of Standard
Prophylactic Care and Secondary outcome of Comparative assessment of
severity of Covid-19 infection in subjects taking YASHTIMADHU TABLET
and those not
taking it in following situations: a) Assessment
of subjects not requiring hospitalization b) Severity
of symptoms of hospitalized patients in wards c) Patients
requiring ICU admission / Ventilator support, Global assessment of overall
change as per the investigator (Efficacy assessment) Safety assessment by
evaluation of occurrence of AE/SAE due to consumption of Ayurveda
Intervention |
