| CTRI Number |
CTRI/2015/02/005574 [Registered on: 24/02/2015] Trial Registered Prospectively |
| Last Modified On: |
30/11/2018 |
| 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 in Health & Immunity related Parameters in Healthy children |
|
Scientific Title of Study
|
A Two Arm, Randomized, Open Labeled, Prospective, Clinical Study to Evaluate efficacy and safety of Dabur Chyawanprash in Health & Immunity related Parameters in Healthy children – A School Based Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Deshpande |
| Designation |
Lecturer |
| Affiliation |
Department of Kayachikitsa, PDEAs College of Ayurveda and Research Center |
| Address |
PDEAs College of Ayurveda and Research Center Sector 25 Akurd Pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
09763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Gupta |
| Designation |
Head Medical Affairs and Clinical Research |
| Affiliation |
Dabur India Limited |
| Address |
No 22 Site IV Dabur Research and Development centre Dabur India ltd
Sahibabad Ghaziabada
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
09910200255 |
| Fax |
0120-4552645 |
| Email |
arun.gupta@dabur.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research |
| Address |
Target Institute of Medical Education and Research
205 B Wing Blue Diamond Society
Nayagoan Dahisar (West), Mumbai
Thane
MAHARASHTRA
400068
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Limited |
| Address |
Dabur India Limited Plot No.22 Site IV Sahibabad GHAZIABAD |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Deshpande |
Maharashtra Arogya Mandal s Sumatibai Shah Ayurved Mahavidyalaya and Ayurvedic Hospital |
Department of Kayachikitsa,Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411 028
Pune
MAHARASHTRA |
09096082950
dr.vaishalid@gmail.com |
| Dr Shailesh Deshpande |
PDEAs College of Ayurveda and Research Center |
Department of Kayachikitsa, PDEAs College of Ayurveda and Research Center Sterling Multi speciality Hospital Sector 25 Akurdi Pradhikaran Nigadi Pune 411044
Pune
MAHARASHTRA |
09763104451
dr.shaileshd@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PDEAs College of Ayurveda and Research Center,Sector 25, Pradhikaran Nigadi Pune 411044 |
Approved |
| Institutional Review Board for Research Maharashtra Arogya Mandals Sumatibhai Shah Ayurveda Mahavidyalaya and Ayurveda Hospital Sane Guruji Arogya kendra Malwadi Hadapsar Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy School Going Children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Chyawanprash |
Dabur Chyawanprash is a multiple ingredient ayurvedic formulation. Chyawanprash also helps to provide strength, stamina and energy. It has to be taken Half teaspoon (approx. 6 gm) followed by a cup of milk twice daily orally for 180 days.
The cup of milk will be between 100-200 ml |
| Comparator Agent |
Milk |
A cup of milk twice daily for 180 days. The Cup of milk will be between 100-200 ml |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 Healthy children of either sex of 5-12 years (both inclusive)
2 Ready to provide informed consent from parent/ legally accepted guardian
3 No significant medical or surgical disease/s at the time of screening
4 No history of allergic conditions to Chyawanprash like products/any ingredients of the Chyawanprash and are not averse to consuming Chyawanprash for the study period
5 Willing to come for the follow up visits for evaluation |
|
| ExclusionCriteria |
| Details |
1 Presence of any clinically significant medical or surgical condition requiring long term treatment
2 Subjects participating/participated in another clinical study within 3 months before recruitment
3 Evidence of significant uncontrolled concomitant disease which in the Investigators opinion would preclude patient participation
4 Immunologically compromised children |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of immunity through episodes severity and duration of illness (infections or allergies) in the two study groups based on subject diary |
180 days (6 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will done in two study groups - immunity through no of children having infections or allergies, difference of absent days in school due to infections or allergies,no of children for absent days in school due to infections or allergies, change in energy levels, physical fitness, strength and stamina and no of children having change in energy levels, physical fitness, strength &stamina & change in quality of life & Physicians Global evaluation on CGI-I Scale and safety and tolerability |
180 days (6 Months) |
|
|
Target Sample Size
|
Total Sample Size="720"
Sample Size from India="720"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="702" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/02/2015 |
| Date of Study Completion (India) |
08/02/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Two Arm, Randomized, Open Labeled, Prospective, Clinical Study to Evaluate efficacy and safety of Dabur Chyawanprash in Health & Immunity related Parameters in Healthy children. The study will be multicentric, and healthy subjects in the age group of 05-12 years will be randomized to either of the two groups i.e. Group A - Dabur Chyawanprash followed by milk twice daily and Group B - only milk twice daily in 1:1 ratio.The glass of milk may be between 100-200 ml. Treatment period will be of 180 days with total visit of 8 visits including screening and randomization. Expected no of completers for the study is planned to be 600 subjects . The study would include various assessment parameters to assess the quality of life (QOL), number of episodes, severity and duration of illness during the study period, level of Energy, overall health status, level of physical fitness, level of stamina and physical strength and assessment of safety. |