| CTRI Number |
CTRI/2014/07/004804 [Registered on: 31/07/2014] Trial Registered Prospectively |
| Last Modified On: |
11/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to evaluate efficacy and safety in health & immunity related parameters of Dabur Ratnaprash formulation |
|
Scientific Title of Study
|
A two arm randomized, open labeled, prospective, multi-centre, clinical study to evaluate efficacy and safety of Dabur Ratnaprash in health & immunity related parameters |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DA/RATN/01/2014 Version1.0 Dated 19 May 2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shailesh Deshpande |
| Designation |
Principal Investigator |
| Affiliation |
PDEAs College of Ayurveda and Research Center |
| Address |
PDEAs College of Ayurveda and Research Center
Sterling Multi speciality Hospital Sector 25
Near Bhel Chowk Akurdi 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 |
Dabur Research and Development Centre Dabur India Ltd
Plot No.22 Site IV Sahibabad, Ghaziabad UP
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
0120-3378614 |
| Fax |
01204552645 |
| 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
Mumbai
MAHARASHTRA
400068
India |
| Phone |
9322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dabur India Ltd |
| Address |
Dabur Research and Development Centre Dabur India Ltd
Plot No.22 Site IV Sahibabad Ghaziabad – 201 010
UP India
|
| Type of Sponsor |
Other [Healthcare and FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir P Pande |
Ayurveda Research Center |
Ayurveda Research center
Dept. of Rasashastra & B Kalpana Ayurved seva sangh Nasik Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@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 Near Bhel Chowk Akurdi Pradhikaran Nigadi
Pune
MAHARASHTRA |
09763104451
dr.shaileshd@gmail.com |
| Dr Sachin Agival |
Shree Gurudeo Ayurved College |
Department of Swasthavrita, Shree Gurudeo Ayurved College
Gurukunj Dist Amravati
Maharashtra
Amravati
MAHARASHTRA |
09421829197
sachin.agiwal@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda Research Center Ayurved Seva Sangh Nasik |
Approved |
| Institutional Ethics Committee PDEAs College of Ayurveda and Research Center Pune |
Approved |
| Institutional Ethics Committee Shree Gurudeo Ayurved College Gurukunj Amravati |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Immunity and Health related parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dabur Ratnaprash |
Dabur Ratnaprash is a chyawanprash like formulation with multiple Ayurvedic ingredients mainly comprising of herbs. It is nutritious and good for health & well being and helps to keep you energetic and active.It has to be taken one teaspoon (approx. 12 gm) followed by milk twice daily for 90 days.The glass of milk may be between 100-200 ml |
| Comparator Agent |
Milk |
Glass of milk twice daily for 90 days. The glass of milk may be between 100-200 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
•Male and female subjects aged 18 to 60 years (both the ages inclusive)
•Ready to provide written informed consent
•No history of any known allergy with Chyawanprash like products or any of the ingredientts of the Ratnaprash
•Willing to come for the follow up visits for evaluation
|
|
| ExclusionCriteria |
| Details |
•Presence of clinically significant abnormal laboratory, ECG or X-ray findings during screening.
•Patients with known uncontrolled diabetes mellitus (DM), hypertension (HT), symptomatic congestive heart failure (CHF), unstable angina pectoris, myocardial infarction (MI)
•Patients participated in another clinical drug trial within 3 months before recruitment in this trial
•Any other medical condition that in the Investigators opinion would preclude patient participation
•Pregnant and breast feeding women and women of child bearing age refusing to use contraceptive measures
•Immunologically compromised individuals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of quality of life (QoL) and number of episodes, severity and duration of illness during the study period |
90 days (3 months) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability |
90 days (3 months) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
The study will be a multicentre, randomized, open label, parallel-group study which is intended to evaluate the safety and efficacy of Dabur Ratnaprash in health and immunity parameters. Healthy subjects in the age group of 18-60 years will be randomized to either of the two groups i.e. Ratnaprash followed by milk and only milk group twice daily in 1:1 ratio.The
glass of milk may be between 100-200 ml. Treatment period will be of 90 days with total visit of 5 visits including screening. Total completers for the study is planned to be 100 subjects. The following parameters will be evaluated like Physical examination, Vital signs, Assessment of level of Energy and overall health status, physical fitness, level of endurance or stamina and physical strength, level of stress, Physician’s Global evaluation, Laboratory parameters for safety and immunity and Palatability etc at various intervals of time.
|