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CTRI Number  CTRI/2023/07/055066 [Registered on: 11/07/2023] Trial Registered Prospectively
Last Modified On: 08/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic management of overweight in children 
Scientific Title of Study   Clinical study on effectivness of Virechana in the Management of Sthoulya (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 Kavya 
Designation  Post Graduate Scholar 
Affiliation  SDM College Of Ayurveda and Hospital Hassan 
Address  SDM College Of Ayurveda and Hospital Department Of Kaumarabhritya Room No 16 Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  8050827702  
Fax    
Email  kavyauppar016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nayan Kumar S 
Designation  Associate Professor 
Affiliation  SDM College Of Ayurveda and Hospital Hassan 
Address  SDM College Of Ayurveda and Hospital Department Of Kaumarabhritya Room No 16 Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  8197589426  
Fax    
Email  drnayanpanaje@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nayan Kumar S 
Designation  Associate Professor 
Affiliation  SDM College Of Ayurveda and Hospital Hassan 
Address  SDM College Of Ayurveda and Hospital Department Of Kaumarabhritya Room No 16 Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  8197589426  
Fax    
Email  drnayanpanaje@gmail.com  
 
Source of Monetary or Material Support  
SDM College Of Ayurveda and Hospital Hassan 
 
Primary Sponsor  
Name  SDM College Of Ayurveda and Hospital Hassan 
Address  SDM College Of Ayurveda and Hospital B M Road Thanniruhalla Hassan Karnataka 573201  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kavya  SDM College of Ayurveda and Hospital Hassan  Room no 16 Department Of Kaumarabhritya Hassan Karnataka
Hassan
KARNATAKA 		 8050827702

kavyauppar016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: sthoulya, ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charaka Samhita, Procedure details: virechana medicine given orally based on agni,vaya,koshta )
(1) Medicine Name: trivrit leha, Reference: Astanga hridaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 30(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Children of 8 to 15 years fulfilling the diagnostic criteria irrespective gender
Who are ready to give informed written assent
Whose parents are willing to participate their child in the study after giving informed consent
 
 
ExclusionCriteria 
Details  Children diagnosed with genetic disorders like Down syndrome and Turner syndrome
Children diagnosed with neurological disorders like epilepsy and cerebral palsy
Children diagnosed with neurodevelopmental disorders like Autism and ADHD
Children diagnosed with endocrine disorders like cushings syndrome and Diabetes mellitus
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
weight will be assessed   after 1 week  
 
Secondary Outcome  
Outcome  TimePoints 
Body mass index
Waist circumference
Abdominal girth
Midarm circumference
Chest circumference 		 after 1 week of the treatment 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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 3 
Date of First Enrollment (India)   29/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/07/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kavyauppar016@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-12-2025?
    Response (Others) -  one year post publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The Objective of the study is to Evaluate the effectivness of Virechana in the management of sthoulya in children. 20 subjects with sthoulya will be conducted  Virechana. The subjects will be assesed using suitable scoring parameters.  
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