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CTRI Number  CTRI/2024/10/075109 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Is guggulu with sthoulyahara kashaya more effective than only sthoulyahara kashaya in the management of sthoulya with special reference to Obesity. 
Scientific Title of Study   A Randomized Controlled Clinical Comparative Study Of Guggulu With Sthoulyahara Kashaya And Sthoulyahara Kashaya In Sthoulya With Special Reference To Obesity 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prajakta Ramesh Gokhale  
Designation  PG scholar Kayachikitsa  
Affiliation  Government Ayurvedic college Vazirabad Nanded 
Address  Department of Kayachikitsa government Ayurvedic college Nanded Maharashtra India 431601 Nanded Maharashtra India

Nanded
MAHARASHTRA
431601
India 
Phone  9834730165  
Fax    
Email  prajaktagokhale22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vidya S Boinwad  
Designation  Assistant Professor  
Affiliation  Government Ayurvedic college Vazirabad Nanded 
Address  Department of Kayachikitsa government Ayurvedic college Vazirabad Nanded Maharashtra India Nanded 431601

Nanded
MAHARASHTRA
431601
India 
Phone  9503609432  
Fax    
Email  vidya.shyam.kore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vidya S Boinwad  
Designation  Assistant Professor  
Affiliation  Government Ayurvedic college Vazirabad Nanded 
Address  Department of Kayachikitsa government Ayurvedic college Vazirabad Nanded Maharashtra India Nanded 431601

Nanded
MAHARASHTRA
431601
India 
Phone  9503609432  
Fax    
Email  vidya.shyam.kore@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic college vazirabad Nanded 431601 INDIA MAHARASHTRA  
 
Primary Sponsor  
Name  Dr Prajakta Ramesh Gokhale  
Address  Department of Kayachikitsa government Ayurvedic college Vazirabad Nanded 431601 Nanded Maharashtra India  
Type of Sponsor  Other [self ] 
 
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 Prajakta Ramesh Gokhale  Government Ayurvedic College and hospital, Nanded   Department of Kayachikitsa, Government Ayurvedic College, vazirabad,Nanded Nanded MAHARASHTRA
Nanded
MAHARASHTRA 		 09834730165

prajaktagokhale22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee,Govt.Ayurved College and Hospital, Nanded   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, (2) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Guggulu with Sthoulyahara Kashaya   Medicine name: 1)Guggulu Reference : Bhavprakash Nighantu Karpuradi Varga. Route : Oral Dose : 10ml Empty Stomach Frequency: BD Duration : 5 weeks With 2) Medicine name : Sthoulyahara Kashaya Reference:Sahasrayogam, Kashaya Prakaran Route : Oral Dose Form : Kashaya Dose : 40ml Frequency : BD Duration : 5 weeks 
Comparator Agent  Sthoulyahara Kashaya  Medicine name : Sthoulyahara Kashaya Reference : Sahasrayogam, Kashaya Prakaran Route : Oral Dose Form : Kashaya Dose : 40ml Frequency : BD Duration : 5 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1)Patient between age group 18-45 years.
2) BMI between 25 upto 35.
3) Patients willing for trial, Irrespective of socioeconomic condition of patient,gender 
 
ExclusionCriteria 
Details  1) Pregnant females and lactating mothers.
2) Subjects suffering from any critical illness.
3) Subjects not willing for trial.
4) Patient having Systemic Disorder like CHD, Acute infective hepatitis, or any
other major illness.
5) Patient on steroids. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To see the effect of GUGGULU with STHOULYAHARA KASHAYA on Weight, BMI,
Waist circumference . 		 31 days 
 
Secondary Outcome  
Outcome  TimePoints 
1) To asess the efficacy of GUGGULU WITH STHOULYAHARA KASHAYA on signs and
symptoms of sthoulya.
2) To assess the efficacy of Guggulu with sthoulyahara Kashaya on lipid pofile. 		 31 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   24/10/2024 
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="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 - NO
Brief Summary   This study is randomized, controlled, clinical, comparative study of Guggulu 1gm BD with Sthoulyahara kashaya 40ml BD for 31 days in sthoulya with special reference to obesity. This study is conducted as PG course at single centre. 
 
 
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