FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/085250 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   efficacy of powder massage and steam bath followed by purgation therapy in central obesity and pear shape obesity a comparative clinical study 
Scientific Title of Study   Efficacy of Udvartana and Bashpa Sweda followed by Virechana Karma in Android Obesity and Gynoid Obesity wsr to Sthoulya A Comparative Clinical Study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  chandana u 
Designation  postgraduate scholar 
Affiliation  sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 
Address  room no 1 panchakarma dept sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar bengaluru 560 104

Bangalore
KARNATAKA
560104
India 
Phone  9342327455  
Fax    
Email  chandananavya20@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  dr vinay kumar k n  
Designation  professor and hod 
Affiliation  sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 
Address  room no 1 panchakarma dept sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar bengaluru 560 104

Bangalore
KARNATAKA
560104
India 
Phone  9845617690  
Fax    
Email  knv.gowda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr vinay kumar k n  
Designation  professor and hod 
Affiliation  sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 
Address  room no 1 panchakarma dept sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar bengaluru 560 104


KARNATAKA
560104
India 
Phone  9845617690  
Fax    
Email  knv.gowda@gmail.com  
 
Source of Monetary or Material Support  
chandana u sri kalabyraveshwara ayurvedic medical college hospital and research center 10th pipline road r p c layout vijaynagar bengaluru 560104 india 
 
Primary Sponsor  
Name  chandana u 
Address  sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar bengaluru 560 104  
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 kiran m goud  sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre  department of panchakarma room no 1 sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre 10 pipeline road rpc layout vijayanagar bengaluru 560 104
Bangalore
KARNATAKA 
9845109556

kiranmgoud@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
sri kalabyraveshwara ayurvedic medical college hospital and research centre  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: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charaka samhitha, Procedure details: Procedure details: poorvakarma udwartana with mustadi ghana choorna for 7 days. snehapana till samyak snigdha lakshanas, 3days of vishrama kala with moorchita aila abhyanga & bashpa sweda, next on the day of virechana karma assesment of vegiki, shuddhi & maniki will be done)
(1) Medicine Name: mustadi ghana choorna, Reference: sushrutha samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1500(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: moorchita taila, Reference: bhavaprakasha, Route: Oral, Dosage Form: Taila, Dose: 450(ml), Frequency: od, Duration: 7 Days
(3) Medicine Name: trivrut lehya, Reference: charaka samhiha, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: charaka samhiha, Procedure details: poorvakarma udwartana with mustadi ghana choorna for 7 days. snehapana till samyak snigdha lakshanas, 3days of vishrama kala with moorchita aila abhyanga & bashpa sweda, next on the day of virechana karma assesment of vegiki, shuddhi & maniki will be done )
(1) Medicine Name: mustadi ghana choorna, Reference: susrutha samhitha , Route: Topical, Dosage Form: Churna/ Powder, Dose: 1500(g), Frequency: od, Duration: 7 Days
(2) Medicine Name: moorchita taila, Reference: bhavaprakasha, Route: Oral, Dosage Form: Taila, Dose: 450(ml), Frequency: od, Duration: 7 Days
(3) Medicine Name: trivrut lehya, Reference: charaka samhitha , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 100(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  subjects of either gender in between the age group of 18 to 60 years
subjects presenting with the pratyatma lakshanas of sthoulya
subjects fit for udvartana
subjects fit for virechana karma
subject with waist hip ratio greater than 0.9 in males and greater than 0.8 in females android obesity

lesser than 0.9 in males and lesser than 0.8 in females gynoid obesity
subjects with asian bmi more than 23
 
 
ExclusionCriteria 
Details  subjects presenting with history of any other major systemic disorders that may interfere with the course of treatment
patient with history of secondary causes to obesity
pregnant and lactating women
 
 
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 assess improvement in signs and symptoms of sthoulya by using bmi waist hip ratio skin fold thickness body composition analyser data and other parameters using one treatment modality   time period between 17 to 25 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   20/05/2025 
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 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  

                in recent times diet pattern has been globally changing, consumption of energy dense foods consisting of high fats and sugars decrease in physical activity due to occupational demand more access to transportation and increased urbanization without preventive measures leads to manifestation of many systemic complications like obesity type 2 diabetes mellitus hypertension osteoarthritis hyperlipidemia coronary artery diseases stroke hormone dependent cancer and polycystic ovary syndrome etc

               obesity is defined as a state of excess adipose tissue due to an enlargement of fat cell size (hypertrophic obesity) or an increase in fat cell number (hyperplastic obesity) or a combination of both in 2022 2.5 billion adults aged 18 years and older were overweight including over 890 million adults who were living with obesity this corresponds to 43% of adults aged 18 years and over (43% of men and 44% of women) who are overweight in 2021 the who estimated that obesity caused at least 2.8 million deaths annually on average obesity reduces life expectancy by 6 to 7 years

                      obesity has diverse presentations of fat distribution in the body which can be categorized as android and gynoid obesity android obesity is characterized with excessive accumulation of fat in the abdominal region especially around waist and upper body resembling an apple shape whereas the gynoid obesity has excessive accumulation of fat in the lower body particularly in the hips thighs and buttocks resembling pear shape in asian ethnic group the bmi of 23 and above is considered to be overweight obese and morbidly obese and this almost resembles the vagbhatas classification of hina madhyama and adhika sthula the measurement of waist to hip ratio plays an important role in determining an individuals proportions of android and gynoid obesity fat distribution              

               the management of obesity in contemporary system of medicines includes lifestyle advice weight loss diets drugs and bariatric surgical treatment though they are being practiced there are no encouraging results in achieving long term therapeutic effects and have the tendency to cause adverse effects hence it is the need of the hour to develop treatment protocol to have a better management in this condition.

               in ayurveda obesity can be compared to sthoulya it is caused due to vitiation of these three morbid entities ie sleshma meda and mamsa wherein android obesity may present with dominance of sleshma and mamsa while gynoid obesity may present with dominance of sleshma and meda the concept of sleshma samvibhajya prayojayet highlights the factors to be considered in the management of sthoulya sthoulya is one among the santarpanajanya vyadhis sleshma nanatmaja vikaras medopradoshaja vikara and kleda pradhana vyadhi charaka mentions medomamsa ativrudhi chalatwa of sphik udara and sthana lambana as the cardinal symptoms of sthoulya acharya sushruta emphasizes rooksha udvartana vyayama and lekhana basti madhu shilajatu prayoga medohara loha etc have been explained as line of management rookshana in the form of udvartana can be employed as vishista poorvakarma with mustadi gana choorna bashpa sweda with ushna jala which has nayati dravatva action can be considered as ushma sweda moorchita tila taila is the formulation of universal choice for both bahya snehana and abhyantara shodhanaga snehapana as it is indicated in pravridda sleshma and medasaka conditions considering sthoulya to be bahudoshaavastha and santharpanojanititha vyadhi samshodhana in the form of langana is mentioned among the pathya trivruth a sukha virechaka has been used for virechana karma in present study

               thus by considering the above factors a clinical study will be undertaken to evaluate the therapeutic efficacy of sarvanga udvartana with mustadi gana choorna and bashpa sweda followed by virechana karma in android obesity and gynoid obesity wsr to sthoulya

 
Close