| CTRI Number |
CTRI/2026/04/107755 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to compare the effect of Purgation therapy followed by Navaka Guggulu tablet and Varunadi decoction fortified Guggulu in reducing weight of Obesity patients |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Virechana followed by Navaka Guggulu and Varunadi Ghana Kashaya Bhavitha Guggulu in Sthoulya Vis-À-Vis Obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 047 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amogh kulkarni |
| Designation |
Post graduate Scholar |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre |
| Address |
Department of kayachikitsa Room no 02 num 10 pipeline road vijaynagar 2nd stage Hampi nagar RPC layout Bangalore
vijaynagar bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
8497834261 |
| Fax |
|
| Email |
kulkarniamogh486@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunatha Adiga |
| Designation |
Professor |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre |
| Address |
Department of kayachikitsa Room no 02 num 10 pipeline road vijaynagar 2nd stage Hampi nagar RPC layout Bangalore
vijaynagar bangalore
Bangalore
KARNATAKA
560104
India |
| Phone |
9035715798 |
| Fax |
|
| Email |
adiga.manjunatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunatha Adiga |
| Designation |
Professor |
| Affiliation |
Sri kalabyraveshwaraswamy ayurvedic medical college hospital and research centre |
| Address |
Department of kayachikitsa Room no 02 num 10 pipeline road vijaynagar 2nd stage Hampi nagar RPC layout Bangalore
vijaynagar bangalore
KARNATAKA
560104
India |
| Phone |
9035715798 |
| Fax |
|
| Email |
adiga.manjunatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Amogh Kulkarni
Department of Kayachikitsa
Room no 02
Sri Kalabyraveshwara Swamy Medical College Hospital And Research Centre
10 Pipeline Rd Vijaynaagar 2nd stage
Hampi Nagar RPC Layout Bengaluru 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Amogh Kulkarni |
| Address |
Department of Kayachikitsa
Room no 02
Sri Kalabyraveshwara Swamy Medical College Hospital And Research Centre
10 Pipeline Rd Vijaynaagar 2nd stage
Hampi Nagar RPC Layout Bengaluru 560104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Amogh Kulkarni |
sri kalabyreshwara swamy ayurvedic medical college hospital and research centre |
Department of Kayachikitsa
Room no 02
10 Pipeline Rd Vijaynagar 2nd stage
Hampi Nagar RPC Layout Bengaluru
Bangalore
KARNATAKA |
8497834261
kulkarniamogh486@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRr |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E66||Overweight and obesity. 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: deepana pachana with chitrakadi vati
Snehapana with Moorchitha Tila Taila
Vishrama Kala Sarvanga Abhyanaga with Moorchitha Tila Taila
Virechana with Trivrut Lehya )
(1) Medicine Name: navaka guggulu, Reference: bhavaprakasha, Route: Oral, Dosage Form: Guggulu, Dose: 2(g), Frequency: bd, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: charka samhitha, Procedure details: deepana pachana with chitrakadi vati
Snehapana with Moorchitha Tila Taila
Vishrama Kala Sarvanga Abhyanaga with Moorchitha Tila Taila Virechana with Trivrut Lehya )
(1) Medicine Name: Varunadi Gana Kashaya Bhavitha Guggulu, Reference: Ashtanga Hridya, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects belonging to the age group of 18-60 years
Subjects of either gender presenting with clinical features of Sthoulya.
BMI more than or equal to 25.0 to 34.9 according to WHO.
|
|
| ExclusionCriteria |
| Details |
Any systemic diseases that interfere with the course of treatment.
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 evaluate the efficacy of Shodana followed by oral administration of Navaka Guggulu in the management of Sthoulya with special reference to Obesity.
To evaluate the therapeutic efficacy of Shodhana followed by oral administration of Varunadhi gana kashaya bhavitha Guggulu in the management of Sthoulya
With special reference to obesity.
To compare the therapeutic efficacy of both the groups in Sthoulya with special reference to obesity |
1 Year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
Not Applicable |
|
|
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)
|
27/04/2026 |
| 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="1"
Days="5" |
|
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
|
Obesity is a condition caused by caloric imbalance where energy intake exceeds energy expenditure commonly due to unhealthy diet and sedentary lifestyle In 2022 about 16 percent of adults worldwide were obese According to WHO a BMI 25 is considered overweight and 30 is obesity Hormonal imbalance also contributes to excess fat accumulation If untreated obesity can lead to metabolic syndrome and cardiovascular disordersIn Ayurveda Sthoulya is classified as a Santarpanajanya Vyadhi caused by excessive intake of shleshmala and medovruddhikara foods lack of physical activity divaswapna and achinta These factors lead to agnimandya ama formation medodhatu vriddhi and margavarana resulting in atisthoulya Acharya Charaka included atisthula under Ashta Nindita Purusha characterized by excess fat deposition in sphik udara and sthanaAs Sthoulya is considered a Bahudoshaja and Santarpanajanya Vyadhi Shodhana therapy is indicated Virechana karma is advised for srotoshodhana and agni normalization Moorchita Tila Taila is ideal for snehapana due to its ushna tikshna and deepana properties aiding in meda reduction and kapha vata pacification. |