| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | 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 | | 2 | Intervention Arm | Procedure | - | 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 |