| CTRI Number |
CTRI/2024/05/067723 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the efficacy of Vidangadi Churna and Sthaulyahar Kashaya in Obesity in Adolescent children. |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the efficacy of Vidangadi Churna and Sthaulyahar Kashaya in Sthaulya w.s.r. to the Obesity in Adolescence |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Rakesh Sharma |
| Designation |
Prof and Head,Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola, Teh.Baijnath Affliation Distt.Kangra, H.P. |
| Address |
Room No. 217, Anatomy Block, RGGPG Ayurvedic College and
Hospital, Paprola, Kangra
Pandol Road, Teh-Baijnath, Distt.-kangra, H.P., Pin-176115
Himachal Pradesh-176115, India
Pandol Road, Teh-Baijnath, Distt.-kangra,
Himachal Pradesh-176115,
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Prof and Head,Department of Kaumarbhritya |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola, Teh.Baijnath Affliation Distt.Kangra, H.P. |
| Address |
Room No. 217, Anatomy Block, RGGPG Ayurvedic College and
Hospital, Paprola, Kangra
Pandol Road, Teh-Baijnath, Distt.-kangra, H.P., Pin-176115
Himachal Pradesh-176115, India
Pandol Road, Teh-Baijnath, Distt.-kangra,
Himachal Pradesh-176115,
HIMACHAL PRADESH
176115
India |
| Phone |
9418105049 |
| Fax |
|
| Email |
hodkbpaprola8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Chaudhary |
| Designation |
MD Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital,Paprola, Teh.Baijnath Distt.Kangra, H.P. |
| Address |
Room no-802
RGGPG Ayurvedic College and Hospital,Paprola, Teh.Baijnath Distt.Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8894678700 |
| Fax |
|
| Email |
docmt4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Govt. Ayurvedic Pharmacy Paprola, Distt.Kangra, Herbal Garden and
Herbarium, Research Institute in ISM, Jogindernagar, Distt.Mandi |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola, Teh.Baijnath
Distt.Kangra, H.P. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Rakesh Sharma |
RGGPG Ayurvedic College,Paprola |
Room No. 217, Anatomy Block, RGGPG Ayurvedic College and
Hospital, Paprola, Kangra, Himachal Pradesh
andol Road, Teh-Baijnath, Distt.-kangra, H.P., Pin-176115 Kangra
Himachal Pradesh-176115,India
Kangra
HIMACHAL PRADESH
176115
Kangra
HIMACHAL PRADESH |
9418105049
hodkbpaprola8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee (Human), RGGPG Ayurvedic College and Hospital Paprola Distt Kangra HP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Churna, Reference: Chakradutta,Sthaulya Chikitsa 36/5, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -- | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sthaulyahar Kashaya, Reference: Sahastrayogam,Kashaya Prakrana Page No 35, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children between age group of 12-16 years
2.Children having BMI more than 85 percentile of CDC growth chart 2000. ii
3.Patients/Parents willing to participate in the trial.
4.Children with unhealthy eating patterns .
|
|
| ExclusionCriteria |
| Details |
1.Children having age less than 12 years and above 16 years.
2.Children having BMI less than 85 percentile of CDC growth chart 2000.
3.Children with Genetic, Hepatic, Renal, Cardiac disorders & physical disability.
4.Children / Parents not willing to participate in the trial. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfilment of Objective and Subjective criteria |
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Control of Obese Patients |
4th and 8th week |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
I would like to publish my research trial after completion as soon as possible.A total 40 subjects will be studied in two groups. 20 Patients will be managed with Vidangadi Churna and 20 Patients will be managed with Sthaulyahar Kashaya. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools. |