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CTRI Number  CTRI/2025/03/083564 [Registered on: 27/03/2025] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to observe the effect of mustadikwath ghanwati with patol yush and mustadikwath ghanwati alone in treating obesity .  
Scientific Title of Study   A randomised clinical study to evaluate add on effect of patol yush as an aahariya kalpana over mustadikwath ghanwati in the management of sthaulya 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  Shivani Bapusaheb Jasud 
Designation  M.D. (First year), Swasthavritta 
Affiliation  R. A. Podar Medical (Ayu.) College, Worli, 400018 
Address  Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra

Mumbai
MAHARASHTRA
400018
India 
Phone  9284733108  
Fax    
Email  shivanijasud7@gmail.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr. Vrushali Khandekar 
Designation  Associate professor 
Affiliation  R. A. Podar Medical (Ayu.) College, Worli, 400018 
Address  Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra

Mumbai
MAHARASHTRA
400018
India 
Phone  7588654776  
Fax    
Email  ujedevrushali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shivani Bapusaheb Jasud 
Designation  M.D. (First year), Swasthavritta 
Affiliation  R. A. Podar Medical (Ayu.) College, Worli, 400018 
Address  Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra

Mumbai
MAHARASHTRA
400018
India 
Phone  9284733108  
Fax    
Email  shivanijasud7@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shivani Bapusaheb Jassud 
Address  Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, 400018 
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 Shivani Bapusaheb Jasud  M. A. Podar Ayurvedic Hospital, Worli, Mumbai 400018  OPD no.16, Swasthyarakshan OPD, Swasthavritta Department, M. A. Podar Ayurvedic Hospital, Dr. Annie Besant Road, Worli, Mumbai 400018
Mumbai
MAHARASHTRA 
9284733108

shivanijasud7@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Patol Yush, Reference: Sushrutsamhita Sutrasthan 46/371, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 135(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Mustadikwath Ghanwati, Reference: Charaka Samhita Sutrasthan 23/12-14, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Age group between 18 to 50 years irrespective of gender, caste and religion.
2.BMI 25 to 39.9kg per meter square
3.Subjects showing classical signs and symptoms of Sthaulya like Dourbalya, Swedaatipravruti, Dourghandhya, Nidraadhikya, Kshudhaadhiikya and Pipasa adhikya.
 
 
ExclusionCriteria 
Details  1.Pregnant women
2.Lactating mother
3.Subjects with long term steroid treatment.
4.Subjects having comorbidities like DM, cardiovascular diseases, cancers etc.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the add on effect of patol yush over mustadikwath ghanawati in sthoulya with special reference to obesity.  5 weeks
Follow up every week 
 
Secondary Outcome  
Outcome  TimePoints 
1.To observe the add on effect of patol yush over mustadikwath ghanwati on BMI, waist hip ratio over period of 5 weeks.
2.To observe the add on effect of patol yush over mustadikwath ghanwati on lipid profile over period of 5 weeks. 
5 weeks
Follow up every week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   07/04/2025 
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="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

    The main aim of Ayurveda is to cure diseases and maintain a state of health. Ayurveda focuses on maintaining and restoring the body’s ability to balance itself and fight ailments. Obesity is a chronic, complex disease defined by excessive fat deposits that can impair health. It increases the risk of type 2 diabetes, heart disease, and can affect bone health, reproduction, and the risk of certain cancers. Obesity also impacts the quality of life, including sleep and movement.

    Overweight and obesity are the fifth leading cause of global deaths. According to the World Health Organization (WHO) in 2022, 2.5 billion adults aged 18 years and older were overweight, including over 890 million adults living with obesity. The prevalence of Sthaulya (obesity) is increasing worldwide across all age groups. According to Ayurvedic texts, Sthaulya is a Santarpanjanya Vyadhi and is detailed in the Ashtang Hridaya and Charak Samhita. In obesity, the Medovaha Strotas (fat channels) are affected, leading to the overgrowth of Medodhatu (fat tissue), which ultimately manifests as obesity.

             Weight gain occurs due to an imbalance between energy intake and energy expenditure. According to Acharya Charaka, continuous intake of causative factors aggravates Kaphadosha and Medodhatu due to their similar properties. This increases the obstruction of Meda in the channels, and as a result, Vata in the digestive system becomes hyperactive. This stimulates Agni (digestive fire), causing rapid digestion of food and leading to frequent hunger. If sufficient food is not available, this imbalance can cause severe complications.

    Ayurveda emphasizes the importance of proper nutrition through appropriate food choices, combinations, and cooking methods. Medohara and Kaphanashana diets are recommended in Ayurveda for managing Sthaulya (obesity). Patol Yush is mentioned in the Sushrut Samhita as an effective remedy for treating Medoroga (obesity). It possesses properties such as reducing Kapha, eliminating excess fat, improving digestion, and supporting heart health. This study aims to evaluate the combined effect of Patol Yush as an Aahariya Kalpana (dietary formulation) with Mustadikwath Ghanwati in managing Sthaulya, as Mustadikwath Ghanwati has already shown effectiveness in treating obesity.

              

 
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