CTRI Number	CTRI/2020/05/024981 [Registered on: 02/05/2020] Trial Registered Prospectively
Last Modified On:	14/03/2021
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  09322522252   Fax  8040917253    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 was 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 completers of the study were 696 subjects. A total  721 subjects were recruited in the study.  The study was carried out at the study sites and at community level. Screening of subjects was done after receiving approval from the IEC of the respective site & registration of the study with CTRI.As per computer generated randomization list, subject were assigned, either Group A or Group B. Subject from Group A was provided with 500 gm Jar(s) of Chyawanprash for 45 days (50 gm extra in case follow up is delayed by 5 days). Subjects were 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 were not be provided with any study drug and were asked to take one cup of milk (approx. 200 ml) for 90 days. Both the groups were advised to follow their normal/routine and diet which they are currently following. All participating subjects were 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 was 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) were 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 were measured as secondary outcomes. Results & Conclusion: The study showed encouraging results as preventive remedy in COVID-19 infection. The study concludes that Dabur Chyawanprash plays a significant role in the prevention of infections including COVID-19 infection in the current pandemic. The severity of infections related illnesses including COVID-19 also were lower with the consumption of Dabur Chyawanprash.  When compared between the groups, statistically significantly  lesser number of subjects were found to be infected with COVID-19 in DCP group as compared to subjects in the control group When compared between the groups, statistically significant lesser number of subjects having COVID-19 related symptoms tested positive for COVID-19 in DCP group as compared to subjects in control group When compared between the groups, statistically significant lesser number of episodes of illness related to infection/Immunity (Non-COVID-19) were observed in DCP group as compared to control group WHO ordinal scale showed higher total scores of severity in control group as compared to DCP group at initial level, during the course of the study and the end of the study, signifying lower severity of COVID-19 in subjects taking DCP.  Dabur Chyawanprash also helped to improve the quality of life and was found to be safe for consumption. In view of the data, Dabur Chyawanprash could be one of the prophylactic choices in the management and control of pandemic like COVID-19.