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CTRI Number  CTRI/2023/06/054439 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 26/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Shunthi Ksharadi Yog compared to Navak Guggulu in Sthaulya (Obesity) 
Scientific Title of Study   Randomized Controlled Clinical Trail To Compare Efficacy Of Shunthi Ksharadi Yog With Navak Guggulu In Sthaulya (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 Dipali Swami 
Designation  PhD Scholar Kayachikitsa Dept 
Affiliation  CPGSRA Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune
Same as adress 1
Pune
MAHARASHTRA
411011
India 
Phone  9960003947  
Fax  -  
Email  drdipaliswamis@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SV Deshpande 
Designation  Dean TAMV HOD Kayachikitsa Dept  
Affiliation  CPGSRA Tilak Ayurved Mahavidyalaya 
Address  Department Of Kayachikitsa TAMV pune
Kayachikiysa Dept of Tilak College
Pune
MAHARASHTRA
411011
India 
Phone  9960071113  
Fax  -  
Email  drsvdeshpande61@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Dipali Swami 
Designation  PhD Scholar  
Affiliation  CPGSRA Tilak Ayurved Mahavidyalaya Pune 
Address  Kayachikitsa Department TAMV Pune
Tilak Ayurved Mahavidyalaya 583 2 Jagtap Road Rasta Peth Pune
Pune
MAHARASHTRA
411011
India 
Phone  9960003947  
Fax  -  
Email  drdipaliswamis@gmail.com  
 
Source of Monetary or Material Support  
Tilak Ayurved College And Research Center Pune 
 
Primary Sponsor  
Name  Nil 
Address  - 
Type of Sponsor  Other [] 
 
Details of Secondary Sponsor  
Name  Address 
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 Dipali Swami   Tilak Ayurved Mahavidyalaya   Kayachikitsa Department 583 2 Jagtap Road Rasta Peth Pune 411011
Pune
MAHARASHTRA 		 09960003947

drdipaliswamis@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: Sthaulya , (2) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Shunthi Ksharadi Yog, Reference: Charak Sutra Sthan 21/23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Navak Guggulu, Reference: Bhaishajya Ratnavali 39/43, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients diagnosed with classical signs of sthaulya mentioned in classical text
Age group will be 18-60 years
K/C/O Hypothyroid Patients
BMI between 23.0 kg/m2 to 29.5 kg/m2
Patients of any sex religion and socioeconomical status 
 
ExclusionCriteria 
Details  Patients age less than 18 and more than 60 years
K/C/O Malignancy Poorly controlled DM HT serious hepatic disorder AIDS
Patients with clinical evidence of hearth failure Alcoholic and drug abuser
Pregnant and lactating women
Patients having acute complicated systemic disease or diseases which require long term drug treatment
BMI more than 30 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Shunthi Ksharadi Yog compared to Navak Guggulu in Sthaulya Patients  180 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Report adverse effect of Shunthi Ksharadi Yog if any observed duringstudy Period  180 days 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/07/2023 
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="2"
Months="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 - Anyone

  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 [drdipaliswamis@gmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 31-05-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   I Vd Dipali Swami PhD Scholar in Kayachikitsa at Tilak Ayurved Mahavidyalaya Pune have selected Shunthi Ksharadi Yog ( Cha,chi  )  compared to Navak Guggulu in Management of Stahaulya. for this study. Nowadays market is flooded with over expensive drugs for weight loss where maximum drugs are of no use or less effective on obese patients. This trail is taken from genuine ayurvedic text to find out the effect of Shunthi Ksharadi yog on obese patients .I will also observe adverse effect of Shunthi Ksharadi Yog if any during the study period .Result of this study will provide more evidence based ayurvedic medicine option for the treatment of Sthaulya (Obesity) 
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