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CTRI Number  CTRI/2020/05/025484 [Registered on: 30/05/2020] Trial Registered Prospectively
Last Modified On: 29/05/2020
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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.

 
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