| CTRI Number |
CTRI/2020/05/025088 [Registered on: 09/05/2020] Trial Registered Prospectively |
| Last Modified On: |
08/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of GUDUCHI TABLET on healthy individuals to prevent covid 19. |
|
Scientific Title of Study
|
Observational Study of GUDUCHI TABLET intake as a preventive measure in pandemic of COVID-19 – An open label, Randomized, Controlled, Prospective, Interventional, Community-based Clinical study on healthy subjects |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B vankatshwarlu |
| Designation |
Research officer(Ayu) |
| Affiliation |
Regional ayurveda research instutute vijayawada |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
6301340787 |
| Fax |
|
| Email |
drcvenkat@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B vankatshwarlu |
| Designation |
Research officer(Ayu) |
| Affiliation |
Regional ayurveda research instutute vijayawada |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
6301340787 |
| Fax |
|
| Email |
drcvenkat@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B vankatshwarlu |
| Designation |
Research officer(Ayu) |
| Affiliation |
Regional ayurveda research instutute vijayawada |
| Address |
Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
Krishna
ANDHRA PRADESH
520015
India |
| Phone |
6301340787 |
| Fax |
|
| Email |
drcvenkat@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Ayush government of India |
|
|
Primary Sponsor
|
| Name |
central council for rsearch in ayurvedic sciences |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 K Anumol |
Regional Ayurveda research institute Vijayawada |
Regional Ayurveda research institute for skin disorders , new rajeev nagar Vijayawada
Krishna
ANDHRA PRADESH |
8075021635
dranumolk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Participant will select from area where atleast one covid 19 positive patient available |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchi tablet |
Tab Guduchi 500mg twice daily for one month |
| Comparator Agent |
nil |
nil |
|
|
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 froma 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 |
15th day, 30th day, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of severity of Covid-19 infection in subjects taking GUDUCHI 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)
|
15th day , 30th day and 45 th day |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
There is no available vaccine against COVID-19 infections and no drug with proven clinical efficacy, although there are several candidates that might be effective in prevention or treatment. Encouragingly, the response from the research community to the pandemic of Coronavirus disease 2019 (COVID-19) has been vigorous.Guduchi is Rasayana drug which improves immunity. In This study will give Guduchi tab 500mg twice daily for one month to healthy individuals to prevent Covid 19. We are selecting the patient from community where atleast one covid 19 patient is present.The possible outcomes of thestudy will be Primary outcome 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 outcomev will be
Comparative assessment of severity of Covid-19 infection in subjects taking Guduchi 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)
3. Safety assessment by evaluation of occurrence of AE/SAE due to consumption of Ayurveda Intervention |