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CTRI Number  CTRI/2020/05/024981 [Registered on: 02/05/2020] Trial Registered Prospectively
Last Modified On: 03/12/2020
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 Dabur Chyawanprash as a preventive remedy in pandemic of Covid-19. 
Scientific Title of Study   “Clinical evaluation of Dabur Chyawanprash (DCP) as a preventive remedy in pandemic of COVID-19 – An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study on Healthy individuals.” 
Secondary IDs if Any  
Secondary ID  Registry 
DCP-CVD-19/2020/01 Version 1.0 Dated 22nd April 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Pawankumar Godatwar  
Address  Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9314502834  
Fax  01412635709  
Email  gpawankumar@rediffmail.com  
 
Details Contact Person
Scientific Query

Modification(s)  
Name  Dr Sanjay Tamoli 
Address  A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai

Mumbai
MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details Contact Person
Public Query

Modification(s)  
Name  Dr Sanjay Tamoli 
Address  A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai

Mumbai
MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Dabur India Ltd, Plot No 22, Site IV, Sahidabad, Ghaziabad-201010, UP, India. 
 
Primary Sponsor  
Name  Dabur India Ltd 
Address  Plot No 22, Site IV, Sahidabad, Ghaziabad-201010, UP, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Contact Person  Name of Site  Site Address  Phone/Fax/Email 
Dr Vaishali Deshpande  Khemdas Ayurved Hospital  Department of Kayachikitsa, Ground Floor, OPD No. 8, P.O. Ishwarpura, Tal-Waghodia,
Vadodara
 
9096082950

dr.vaishalid@gmail.com 
Dr Pranita Deshmukh  MAMs SS Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra Malwadi Hadapsar   Department of Research Methodology and Medical Statistics and Lecturer Department of Sharir Kriya, Ground Floor
Pune
 
9822229579

pranitaj@gmail.com 
Dr Pawankumar Godatwar  National Institute of Ayurveda  Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road
Jaipur
 
9314502834

pgodatwar@gmail.com 
Dr Shailesh Deshpande  Parul Ayurveda Hospital,  Department of Kaychikitsa, OPD no 106, Ground Floor, Parul University, P.O.Limba, Tal. Wagholia
Vadodara
 
9763104451

dr.shaileshd@gmail.com 
Dr Raman Ghungralekar  R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli,   OPD No 16, Ground Floor, Department of Kayachikitsa
Mumbai
 
9221100630

ghungralekar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda Madhav Vilas Palace, Amer Road, Jaipur  Approved 
Institutional Ethics Committee on Human Research,(PIA-IECHR)  Approved 
Institutional Ethics Committee, R A Podar Medical College (Ayu) & M.A. Podar Hospital Worli, Mumbai, Maharashtra  Approved 
Institutional Review Board For Research, MAMs SS Ayurveda Mahavidyalaya & Sane Guruji Aarogya Kendra, Malwadi, Hadapsar, Pune, 411028   Approved 
Parul Institute of Ayurved and Researchs Institutional Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Immunity in Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dabur Chyawanprash  Dosage and Treatment Duration: Adults (13 -70 years): One teaspoonful (approx. 12 gm of Chyawanprash) twice daily followed by milk Children (5-12 years): Half teaspoonful (approx. 6 gm of Chyawanprash) twice daily followed by milk  
Comparator Agent  Milk  One cup of milk (approx 200 ml) twice daily 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects meeting all of the following criteria will be included in the trial-
1. Healthy, Male or Female subjects between the age group of 5 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 and 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. Known cases of Diabetes
4. 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. Subjects having a past history of allergy to Chyawanprash like products
8. 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 
1.Comparative assessment of incidence of COVID-19 in subjects taking DCP and those not taking it over a period of 3 months (90 days)
2. Comparative assessment of incidence of other non COVID-19 infections in subjects taking DCP and those not taking it over a period of 3 months (90 days)
 
Day 15,30, 45, 60, 75, 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparative assessment of severity of COVID-19 (when it occurs) in subjects taking DCP and those not taking it. Severity will be graded as per the attached ordinal scale for clinical improvement of COVID-19 published by WHO
 
Day 15,30, 45, 60, 75, 90 
Comparative assessment of changes in Quality of life evaluated on Q-LES-Q-SF   Day 0,45,90 
Comparative assessment of incidence and severity of other allergy related health problems like cough, sneezing, rhinitis, sore throat etc.   Day 15,30, 45, 60, 75, 90 
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.   Day 15,30, 45, 60, 75, 90 
Global assessment of overall change as per the investigator (Efficacy assessment)   Day 90 
Safety assessment by evaluation of occurrence of AE/SAE  Day 0, 15,30, 45, 60, 75, 90 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
Phase of Trial
Modification(s)  
N/A 
Date of First Enrollment (India)
Modification(s)  
15/05/2020 
Date of First Enrollment (Global)  No Date Specified 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Not yet published 
Brief Summary
Modification(s)  
The study is intended to evaluate DCP as a preventive remedy for COVID-19 and other non COVID-19 infections in an open labelled, Multi centric, Randomized, Comparative, Interventional, Prospective Community based design in healthy male and female individuals aged between 5-70 years.The total sample size of the study will be 600 subjects. These subjects will be divided into 2 groups of 300 subjects each. 20% additional subjects (120 additional subjects) will be recruited considering a drop out of 20% i.e. a total of about 720 subjects will be recruited in the study.  The study will be carried out at the study sites and at community level. Screening of subjects will be done after receiving approval from the IEC of the respective site & registration of the study with CTRI.As per computer generated randomization list, subject will be assigned, either Group A or Group B. Subject from Group A will be provided with 500 gm Jar(s) of Chyawanprash for 45 days (50 gm extra in case follow up is delayed by 5 days). Subjects will be advised to take DCP in a dose of one teaspoon twice daily (10 gm) (adults 12-years to 70 years) and ½ teaspoon (5 gm) twice daily (Children 5-12 years) followed by milk (approx. 200 ml) for 90 days. Subjects in Group B will not be provided with any study drug and will be asked to take one cup of milk (approx. 200 ml) for 90 days. Both the groups will be advised to follow their normal/routine and diet which they are currently following. All participating subjects will be asked to follow COVID-19 related guidelines (prevention and containment of infection) provided by the local health authorities and other government agencies from time to time. Any mass mandatory remedy recommended by the Government of India/State or Local Health Authorities will be given to the participating subjects of both the groups. Data will be captured in E-CRFs and E- Diaries. Comparative assessment of incidence of COVID-19  and other infections in subjects taking DCP and those not taking it over a period of 3 months (90 days) will be assessed as primary outcome. Severity of COVID-19, incidences of hospitalisations etc, incidence and severity of other infections and allergies, QOL, GCI and safety assessments will be measured as secondary outcomes. 

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