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CTRI Number  CTRI/2025/02/080972 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic Management of Obesity by Biopurificatory therapy, Diet and Yoga. 
Scientific Title of Study   A clinical study to evaluate the efficacy of vamana karma followed by pathya -ahara and yoga in the management of sthaulya. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Khushboo k Marathe 
Designation  PG Scholar  
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma Parul Institute of Ayurved Parul University PO Limda Tal Waghodia 391760 Dist Vadodara Gujarat India

Vadodara
GUJARAT
391760
India 
Phone  8788129778  
Fax    
Email  drkhushboomarathe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nirmala Sonawane 
Designation  HOD and Professor of Panchakarma 
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma Parul Institute of Ayurved Parul University PO Limda Tal Waghodia 391760 Dist Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax    
Email  ayurved05@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nirmala Sonawane 
Designation  HOD and Professor of Panchakarma 
Affiliation  Parul Institute of Ayurved 
Address  Department of Panchakarma Parul Institute of Ayurved Parul University PO Limda Tal Waghodia 391760 Dist Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax    
Email  ayurved05@gmail.com  
 
Source of Monetary or Material Support  
Panchakarma OPD no- 105 and IPD,Parul Ayurved Hospital ,Parul University ,Limda ,Vadodara,Gujarat India ,pin no - 391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved  
Address  Panchakarma - OPD no-105 and IPD Parul Ayurved Hospital,parul university,Limda,Vadodara, Gujarat India , pin no-391760 
Type of Sponsor  Research institution and hospital 
 
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 Khushboo k Marathe  Parul Ayurved Hospital  Department of Panchakarma Parul Institute of Ayurved Parul University PO Limda Tal Waghodia 391760 Dist Vadodara Gujarat India
Vadodara
GUJARAT 
8788129778

drkhushboomarathe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Human Research Parul Institute of Ayurved Parul University   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: MEDA-DHATUGATAJVARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charak samhita, Procedure details: poorva karma - Deepana,pachana,udvartana,snehapana pradhana karma- vamanakarma paschat karma - samsarjana krama after samsarjana krama pathya ahara and yoga for 15 days)
(1) Medicine Name: Murchita goghrita, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 5 Days
(2) Medicine Name: varunadi kashaya, Reference: Astanga hridaya, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects having sign and symptoms of sthaulya explained in Ayurveda Text
Age between 18years to 60 years irrespective of gender,caste,religion
Subjects having BMI Between 23.1-35kg per metre square
Subjects who are fit for vamana karma, shamana aushadhi and yoga
Subjects Who are ready to give written consents 
 
ExclusionCriteria 
Details  Age less than 18years and more than 60years irrespective of caste, gender and religion
Sthaulya associated with other known diseases like cardiovascular disease, uncontrolled DM, uncontrolled hypothyroidism
Patients who are unable to carryout his or her own physical activities
Pregnant lady
Patients Who are unfit for vamana karma 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in the body weight from baseline  60days 
 
Secondary Outcome  
Outcome  TimePoints 
1 Reduction in the BMI
2 Changes in the lipid profile Reduction in total cholestrol ,LDL,Triglycerides HDL Levels
3 Reduction in the symptoms of Sthaulya 
30-35days 
 
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)   25/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

INTRODUCTION:

Sthaulya is a Santarpanjanya Vyadhi described in Astonindatiya Adhyaya in Sutrasthana of Charaka Samhita. In Sthaulya, Medovaha Srota is affected due to which there is over production of Medodhatu. In modern medical science, Sthaulya is compared with obesity caused by excess calorie intake and also endocrinal   disorders   like Hypothyroidism, Cushing’s syndrome, also drug induced or due to genetic inheritance. Obesity is often defined as a condition of abnormal or excess fat accumulation in adipose tissue to the extent that the health becomes impaired. In santarpanjanit vyadhi sodhana procedures are beneficial. Vamana is one such karma which removes vitiated kapha and medo dosha which are prime dosas involved in Sthaulya. Along with vamana, dietary management and exercise play important role in the management of Sthaulya. Hence, the study aims in integration of various approaches described in Ayurveda             

NEED OF STUDY:                                                                                                       

 A current world health study claims that obesity is included among the fifth selected risk to health. The prevalence rate of obesity in India is 40.3%, in south the ratio is highest and in east is lowest at 32.96% and prevalence ratio is seen more in females as compared to males ratio mentioned is 41.88% versus 38.67%. prevalence rate is high in female as compared to males. Management of Obesity in contemporary science includes various medications like appetite-supressing drugs and bariatric surgeries. They may lead to various side effects like depression, tachycardia, insomnia, bloating etc. There are also chances of bowel obstruction, gallstones, ulcers due to various bariatric surgeries .etc. There is a need of holistic management which would help in a sustainable effect without any undesirable side effects. This study is designed in such a way that most of the causes of obesity can be addressed and the treatment should be cost effective and also feasible for the patient. In this study we are combining vamana, dietary specifications and yoga, this will help the patient to achieve a long-term benefit with sustainable results.

AIM:  To evaluate the efficacy of vamana karma followed by pathya ahara and yoga in the management of Sthaulya

OBJECTIVES

 

         To study the combined effect of vamana karma, pathya ahara and yoga in  the management of Sthaulya.

         To study the changes in biochemical parameters by vamana karma, pathya ahara and yoga in the management of Sthaulya.

 

HYPOTHESIS

Null Hypothesis (H0):Vamana karma followed by pathya –ahara and yoga is not effective in the management of Sthaulya

Alternate Hypothesis(H1): Vamana karma followed by pathya –ahara and yoga is effective in the management of Sthaulya

RESEARCH QUESTION : Whether vamana karma followed by pathya-ahara and yoga is effective in the management of Sthaulya ?

METHODOLOGY

Study Design:  An open labelled single arm clinical trial                                                                                                                                                                              Sample size: 20                                                                                                                                                                                                                                                       Duration of treatment: 30 -35days                                                                                                                                                                                                             Selection criteria: 20 Patient will be selected from OPD and IPD of Parul Ayurveda Hospital                                                                                                                Diagnostic criteria: classical clinical features of Sthaulya  as Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya

Inclusion criteria:                                                                                        

   1.Subjects having sign and symptoms of Sthaulya explained in Ayurveda text              

  2.Age between 18 years to 60 years irrespective of gender, caste, religion         

3.Subjects having BMI between 23.1 to 35kg/m2                                          

 4.Subjects who are fit for vamana karma, shaman ausadhi and yoga.                

  5.Subjects who are ready to give written consents.

Exclusion criteria:                                                                                         

   1.Age less than18years and more than60years                                                                                                                                                                               2.Sthaulya associated with   other known disease like hypertension, cardiovascular disease, uncontrolled hypothyroidism, uncontrolled diabetes mellitus                  3.Patients who are unable to carry out his/her own physical activities                                                                                                                                                               4.Pregnant lady                                                                                                                                                                                                                                              5.Patient unfit for vamana karma                                                                                                                                                                                                                              Assessment criteria :                                                                                                                                                                                                                                1.Subjective criteria- Chala sphika udar stana, Alasya, Dourbalya, Kshudraswasa, Swedaadhikya                                                                                                    2.Objective criteria-BMI, weight, body circumference(chest, waist, pelvis, mid-arm, pelvis, mid-thigh) and lipid profile                                                                               3.Criteria for assesessment of vamana:-                                                                                                                                                                                                          a. Number of vamana vega                                                                                                                                                                                                                       b.Duration of Vamana  Vamana vyapat (complicatios if occur will be noted and treated immediately).                                                                                                              c. Vitals of patient during Vegas  Immediate discomfort to the patient   .                                                                                                                                                  d.Achievement of Pittantika Shuddhi (Samyaka Vamana Lakshana )                                                                                                                                                                   e. Maniki Shuddhi                                                                                                                                                                                                                                               f.Type of Shuddhi                                                                                                                                                                                                                                             g vamana vyapat (complications if occur will be noted and treated immediately)                                                                                                    Study duration – 18 months                                                                                                                                                                                                                          Follow up: on 0th day, after vamana, after completion of treatment, on 60th day 

Shodhana

1.Deepana and Pachana for 3-5 days-   Chitrakadi Vati 2 BD A/F and Amapachak Vati 2BD B/F Along with Udvartana Witth Yava Churna + Triphala Churna        

 2.Snehapana for 3-7 Days with Murchita  Goghrita                                                                                                                                                                          3.Vamana Karma  with Vamana yoga –Madanphala pippali (6gram), yastimadhu churna (3gm), vacha(3gm), madhu(q.s.)                                                        4.Samsarjana Krama for 3/5/7 days.

Shamana and yoga

1.Breakfast – Boiled Moong / Channa /Lajja(Jowar/Bajra).                                                                                                                                                            2. Lunch – Jowar Roti /Seasonal Vegetables/daliya                                                                                                                                                                        3. Dinner – Jowar Roti /Seasonal Vegetables /daliya.                                                                                                                                                                     4.Shamana Aushadhi – Varunadi Kashaya 20ml Bd B/F.

 

Yoga and vyayama

1.Sukshma Kriya for10 mins                                                                                                                                                                                                             2.Suryanamaskar 2 times every morning and increased by 2 per weekly(acc. to strength of patient)

 

 

 

 

 
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