| CTRI Number |
CTRI/2020/09/027658 [Registered on: 08/09/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of varadi kashaya and navak guggulu in childhood obesity |
|
Scientific Title of Study
|
A clinical study of the efficacy of varadi kashaya and navak guggulu in the management of sthaulya w.s.r. to childhood obesity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Usha Damor |
| Designation |
Post Graduation Scholar |
| Affiliation |
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
Room No.154 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Room No.154 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9950625646 |
| Fax |
|
| Email |
3281damorusha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prem Prakash Vyas |
| Designation |
H.O.D. and Associate Professor at P.G.Department Of Kaumarbhritya Dr.S.R.R.A.U. Jodhpur |
| Affiliation |
Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University |
| Address |
Room No.155 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Room No.155 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414351871 |
| Fax |
|
| Email |
drppvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Damor |
| Designation |
Post Graduation Scholar |
| Affiliation |
Dr.S.R.Rajasthan Ayurved University Jodhpur Rajasthan |
| Address |
Room No.154 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Room No.154 PG Department Of Kaumarbhritya Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9414351871 |
| Fax |
|
| Email |
3281damorusha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University karwad Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
UCA DRSRRAU Karwad Jodhpur Rajasthan |
| Address |
U.C.A.DR.S.R.R.A.U.Karwad Jodhpur Rajasthan |
| 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 Usha Damor |
O.P.D. and I.P.D. of Kaumarbhritya DR.Sarvepalli Radhakrishnan Rajasthan Ayurved University |
Hospital of University colledge of Ayurveda DR.Sarvepalli Radhakrishnan Rajasthan Ayurved University Karwad Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9950625646
3281damorusha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Navak guggulu |
10mg per body weight per day
2 times per day in two divided doses
administration oral |
| Intervention |
varadi kashaya |
10mg per body weight per day
2 times per day in two divided doses
administration oral |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
patients shows cardinal feature of childhood obesity will be selected.
A child with BMI 86th percentile 94th percentile and above 95th percentile. |
|
| ExclusionCriteria |
| Details |
Children age below 0-9 years and above 16 years of age.
patients receving drugs like steroids and anti depressents.
childhood obesity due to endocrinal disorders like cushing syndrome,hypothyroidism etc.
A child with a BMI below 5th percentile is not considered. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce weight in obese child |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| maintain healthy weight in chlid |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized,double blind parallel group trial companing the efficacy of varadi kashaya and navak guggulu for 60 days in 40 cases of sthaulya w.s.r.childhood obesity,each group having 20 cases.
|