| CTRI Number |
CTRI/2026/02/103982 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| 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 test and Compare the efficacy of Shadushana Guggulu with Udvartana in Sthoulya (Primary Obesity), with the efficacy of Navaka Guggulu with Udvartana |
|
Scientific Title of Study
|
A randomized open labelled clinical study on the efficacy of Shadushana Guggulu with Udvartana in Sthoulya with specical refernce to primary obesity and its comparision with the efficacy of Navaka Guggulu with Udvartana |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Brunda A P |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room no-5 department of kayachikitsa sri sri college of ayurvedic science and research hospital 21st km kanakapura road udayapura post
Bangalore
KARNATAKA
560082
India |
| Phone |
8618157440 |
| Fax |
|
| Email |
brundabru401@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmyashree U P |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room no-5 department of kayachikitsa, Sri Sri college of Ayurvedic science and Research hospital 21st km kanakapura road Udayapura post Bengaluru Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8618716570 |
| Fax |
|
| Email |
sowmyanaveenbs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmyashree U P |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Room no-5 department of kayachikitsa Sri Sri College of Ayurvedic Science and Research hospital 21st km kanakapura road udayapura post Bengaluru Karnataka 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8618716570 |
| Fax |
|
| Email |
sowmyanaveenbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital,21st KM ,Kanakapura Road Udayapura Banglore Karnataka 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Brunda A P |
| Address |
Room no-5 Kayachikitsa OPD Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura road Udayapura post Bengaluru 560082 Karnataka |
| Type of Sponsor |
Other [Self] |
|
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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 Brunda A P |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room no-5 Kayachikitsa OPD
Sri Sri College of Ayurvedic Science and Research Hospital
Bangalore
KARNATAKA |
8618157440
brundabru401@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 | - | udvartanam, उद्वर्तनम् | (Procedure Reference: Panchakarma textbook by B A Lohit , Procedure details: PURVA KARMA:- Purva Karma includes arrangement of required materials and appropriate preparation of the patient.
PRADHANA KARMA:- In the Pradhanakarma of Udvartana, Triphala Choorna is taken and rubbed over the body of the patient positioned comfortably in pratilomagati using rhythmic upward and circular strokes, for approximately 30-45 minutes.
PASHCAT KARMA:- Paschat Karma of Udwartana involves cleansing the body with warm water bath to remove the residual powder and restore comfort. The patient is then advised to rest and to take Laghu Ahara.
)
(1) Medicine Name: Triphala Choorna, Reference: Bhaishajya Ratnakara. Reprint ed. Delhi: Motilal Banarsidass; 1985. Part 5, Shakaradi Guggulu Prakarana, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadushana Guggulu, Reference: Yogaratnakara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -500mg Shadushana Guggulu along with Ushna Jala 1-0-1 after food | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: --500mg Navaka Guggulu along with Ushna Jala 1-0-1 after food | | 4 | Intervention Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: Panchakarma textbook by B A Lohit, Procedure details: PURVA KARMA:- Purva Karma includes arrangement of required materials and appropriate preparation of the patient. PRADHANA KARMA:- In the Pradhanakarma of Udvartana, Triphala Choorna is taken and rubbed over the body of the patient positioned comfortably in pratilomagati using rhythmic upward and circular strokes, for approximately 30-45 minutes. PASHCAT KARMA:- Paschat Karma of Udwartana involves cleansing the body with warm water bath to remove the residual powder and restore comfort. The patient is then advised to rest and to take Laghu Ahara.)
(1) Medicine Name: Triphala Choorna, Reference: Bhaishajya Ratnakara, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1000(mg), Frequency: od, Duration: 7 Days |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects between the age group of 20 -50 years irrespective of gender, religion, occupation and socio-economic status.
Subjects fulfilling diagnostic criteria.
Subjects who are willing to give a written consent for the treatment, that is conveyed in the local language in which subject can understand.
|
|
| ExclusionCriteria |
| Details |
Subject diagnosed with Secondary Obesity that are due to Hypothyrodism, Diabetes Mellitus and any other medical conditions that leads to Secondary Obesity.
Pregnant and lactating women.
Subjects suffering from uncontrolled systemic illness like Hypertension, Cardiovascular diseases, Diabetes Mellitus and on prolonged concurrent medications which intervene with the course of disease and course of treatment.
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Assessment of Significant changes will be made on basis of grading and scoring of the subjective parameters like Dourbalya, Sveda Pradhurbhava,Atikshudhata ,Trishna, Nidradhikya and Objective parameters like BMI and Anthropometric measurements.
2.Establishment of Clinical Efficacy of Administration Shadushana Guggulu with Udvartana in Sthoulya |
Group A – Triphala Choorna Udvartana with Shadushana Guggulu (Trial group).
Group B – Triphala choorna Udvartana with Navaka Guggulu (Comparitive group).
Trial period: 30 days.
Drug free follow up: 30 days.
Total study duration: 60 days.
Assesments will be done on 0th day, 8th day, 31st day and 60th day for both Trial and Comparitive group
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Generation of data on Significant changes observed in the grading & scoring in Subjective & Objective parameters.
2.Generation of data on possible unexpected or adverse drug reactions or events.
3. Generation in depth ananlysis data on different aspect of the disease. |
Group A – Triphala Choorna Udvartana with Shadushana Guggulu (Trial group).
Group B – Triphala choorna Udvartana with Navaka Guggulu (Comparitive group).
Trial period: 30 days.
Drug free follow up: 30 days.
Total study duration: 60 days.
Assesments will be done on 0th day, 8th day, 31st day & 60th day for both Trial & Comparitive group
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/02/2026 |
| 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="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
|
Obesity is defined as an abnormal
growth of the adipose tissue due to an enlargement of fat cell size
(hypertrophic obesity) or an increase in fat cell number (hyperplasic obesity)
or a combination of both. Primary obesity (Type 1 Obesity) is not
caused by any disease and its prevalence is amongst people who are accustomed
to sedentary lifestyle, alcohol addiction and due to change in food habits and
biological clock disturbance . According to WHO, 1.9 billion adults
above age of 18 years were over-weight, out of which 650 million were obese,in
2022. The prevalence of obesity has been increased multi fold
within the last 20 years and continue to rise. In India, more than 135 million
individuals are affected with obesity with more prevalence of abdominal
obesity. Mortality rate due to obesity and its related complications are
increasing day by day . Obesity is a chronic condition requiring
long-term management due to its associated health risks and high relapse rates.
Despite lifestyle modifications like diet, exercise, and behavioral therapy
being essential for all individuals with BMI more or equal to 25 sustained
weight loss remains challenging .
Pharmacotherapy such as Tetrahydrolipstatin may be considered in higher BMI or
comorbid cases, but treatment options are limited and often have side effects.
Hence, there is a growing need for effective, safe, and sustainable
interventions in obesity management. The trial drug under consideration, Shadushana Guggulu ,is explained in
the Yogaratnakara Medoroga Adhyaya. Navaka guggulu consisting of Maricha, Pippali, Shunti,
Haritaki, Vibhitaki, Amalaki, Chitraka, and Musta mentioned
in Bhaishajyaratnavali , Medoroga chikitsa upakrama being
a proven drug for Medohara is taken as control drug. |