| CTRI Number |
CTRI/2020/05/025484 [Registered on: 30/05/2020] Trial Registered Prospectively |
| Last Modified On: |
04/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
study on the effect of Chyavanprash Lehyam as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 |
|
Scientific Title of Study
|
A prospective non-randomized open labeled controlled interventional study on the effect of Chyavanprash Lehyam as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 |
| Trial Acronym |
CPC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P V V Prasad |
| Designation |
Assistant Director-In charge |
| Affiliation |
NIIMH-CCRAS, Ministry of AYUSH |
| Address |
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Hyderabad
TELANGANA
500036
India |
| Phone |
040-24067388 |
| Fax |
040-24067388 |
| Email |
prasadpeyyala@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P V V Prasad |
| Designation |
Assistant Director-In charge |
| Affiliation |
NIIMH-CCRAS, Ministry of AYUSH |
| Address |
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Hyderabad
TELANGANA
500036
India |
| Phone |
040-24067388 |
| Fax |
040-24067388 |
| Email |
prasadpeyyala@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P V V Prasad |
| Designation |
Assistant Director-In charge |
| Affiliation |
NIIMH-CCRAS, Ministry of AYUSH |
| Address |
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Hyderabad
TELANGANA
500036
India |
| Phone |
040-24067388 |
| Fax |
040-24067388 |
| Email |
prasadpeyyala@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| CCRASNIIMH
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Telangana, INDIA. |
|
|
Primary Sponsor
|
| Name |
CCRASNIIMH |
| Address |
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036, |
| 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 PVV Prasad |
CCRAS-NIIMH, Room no. 112 |
National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Hyderabad
TELANGANA |
040-24067388
040-24067388
prasadpeyyala@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
2. Subjects who are froma community where at least 1 confirmed case is already identified |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CHYWANPRASH LEHYAM |
CHYWANPRASH LEHYAM-12 g X two times a day
(Morning on empty stomach and nigh before going to bed)
for one month |
| Comparator Agent |
Standard Prophylactic Care |
Standard Prophylactic Care recommended by Government of Telangana Health authorities |
|
|
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
|
Open Label |
|
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 |
0 15 30 45 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Assessment of subjects not requiring hospitalization
b) Severity of symptoms of hospitalized patients in wards
c) Patients requiring ICU admission / Ventilator support
3. Safety assessment by evaluation of occurrence of AE/SAE due to consumption of Ayurveda Intervention |
0 15 30 45 day |
|
|
Target Sample Size
|
Total Sample Size="5000"
Sample Size from India="5000"
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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In view of no vaccine /treatment available for
COVID-19 infection as on date, there is a need to investigate the potential
intervention. Although there are lot of Clinical studies are ongoing all over
the world, there is a scope for Traditional systems of Medicine also in these
types of pandemic conditions, where masses of population are affected. It is
imperative that to cater to such a huge population there should be a research
on Traditional systems of medicine also, as these systems are co-existing with
the lifestyles of the people in that particular geographical region. In
Classical textbooks of these traditional medicines such type of outbreaks have
been explained and their possible treatment. This is a attempt to investigate
the role of Ayurveda intervention in prophylaxis of COVID-19 infection to save
the healthy population from being infected. |