| CTRI Number |
CTRI/2019/08/020991 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ROLE OF VIDANGADI CHURNA TO PROMOTE THE PHYSICAL AND MENTAL STRENGTH IN OVERWEIGHT CHILDREN WITH WEIGHT MANAGEMENT |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDANGADI CHURNA IN STHAULYA W.S.R. TO OVERWEIGHT IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr LOKESH KUMAR SHARMA |
| Designation |
M.D. SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF KAUMARBHRITYA,NATIONAL INSTITUTE OF AYURVEDA,MADHAV VILAS PALACE,JORAWAR SINGH GATE,AMER ROAD,JAIPUR,RAJASTHAN.
Jaipur
RAJASTHAN
302002
India |
| Phone |
7737733140 |
| Fax |
|
| Email |
drlokeshsharma07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RAKESH KUMAR NAGAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF KAUMARBHRITYA,NATIONAL INSTITUTE OF AYURVEDA,MADHAV VILAS PALACE,JORAWAR SINGH GATE,AMER ROAD,JAIPUR,RAJASTHAN.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAKESH KUMAR NAGAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
DEPARTMENT OF KAUMARBHRITYA,NATIONAL INSTITUTE OF AYURVEDA,MADHAV VILAS PALACE,JORAWAR SINGH GATE,AMER ROAD,JAIPUR,RAJASTHAN.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414062099 |
| Fax |
|
| Email |
drrknagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF AYURVEDA,JAIPUR |
|
|
Primary Sponsor
|
| Name |
NATIONAL INSTITUTE OF AYURVEDA |
| Address |
NATIONAL INSTITUTE OF AYURVEDA,MADHAV VILAS PALACE,JORAWAR SINGH GATE,AMER ROAD,JAIPUR,RAJASTHAN.PIN CODE-302002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr LOKESH KUMAR SHARMA |
NATIONAL INSTITUTE OF AYURVEDA |
OPD NO.5,DEPARTMENT OF KAUMARBHRITYA,MADHAV VILAS PALACE,JORAWAR SINGH GATE,AMER ROAD,JAIPUR,RAJASTHAN PINCODE-302002
Jaipur
RAJASTHAN |
7737733140
drlokeshsharma07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OVERWEIGHT CHILDREN |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Modification in lifestyle |
Same pattern of diet modification will be followed in both groups which fulfill the caloric requirement of body and instruction chart will be provided for diet and day to day physical and mental exercise. |
| Intervention |
VIDANGADI CHURNA |
Dose of the Vidangadi Churna 1 gm twice a day with honey.Total duration of the intervention will be three month i.e. 2 month clinical trial with drug and one month post drug follow up. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of either sex aged between 10-15 years will be selected.
2.Children with Familial tendency of obesity.
3.Obesity due to sedentary lifestyle and dietary habits.
4.Children having BMI between 85th to 95th percentile of CDC growth charts 2000.
|
|
| ExclusionCriteria |
| Details |
1.Children those are suffering from any systemic and endocrinal illness like DM, Hypothyroidism etc.
2.Obesity associated with chromosomal disorders/metabolic disorders.
3.Children those are already on treatment for obesity or other disorders.
4.Drug induced obesity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of Vidangadi Churna in Overweight children. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To promote the physical and mental strength in overweight children with weight management. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/09/2019 |
| Date of Study Completion (India) |
19/05/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Apply in Journal of Ayurveda, National Institute of Ayurveda, Jaipur |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The present clinical study is a open label randomized control clinical trial to evaluate the efficacy of Vidangadi Churna in overweight children. 30 patients of age group 10-15 years for present clinical study were selected from OPD and IPD of Kaumarabhritya, NIA, Jaipur. Selected patients were randomly divided in group A & group B with 15 patients in each group. Group A were given Vidangadi churna with dose of 1 gm twice a day with Madhu (Q.S). Group B is advised for modification in diet and lifestyle. Same pattern of diet and lifestyle modification followed in both groups which fulfill the caloric requirement of body and instruction chart were provided for diet and day to day activities. Total duration of the intervention was three month i.e. 2 month clinical trial with drug and lifestyle modification and one month post intervention follow up.The primary outcome measures is to evaluate the efficacy of Vidangadi Churna in overweight children. The secondary outcome is to restore normal physical activity and promote healthy lifestyle. |