| CTRI Number |
CTRI/2025/04/085727 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
A Study to Evaluate the Effect of Triphala Along with Standard Care for Sustained Anti-obesity Effect in Central Obesity Adults. |
Scientific Title of Study
Modification(s)
|
Evaluation of Triphala as an Add-on Intervention for Sustained Anti-obesity Effect in Central Obesity: A Randomized Placebo-Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Banappa S Unger |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Traditional Medicine |
| Address |
N3-01, Department of Pharmacology and Toxicology, Third floor Block 1, ICMR National Institute of Traditional Medicine Opposite to KLE hospital Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439226 |
| Fax |
|
| Email |
banappau@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Barvaliya |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Traditional Medicine |
| Address |
W3-09, Department of Health Systems Research, Third floor Block 1, ICMR National Institute of Traditional Medicine Opposite KLE hospital Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312475477 |
| Fax |
08312475479 |
| Email |
barvaliya.m@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banappa S Unger |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Traditional Medicine |
| Address |
N3-01, Department of Pharmacology and Toxicology, Third floor Block 1, ICMR National Institute of Traditional Medicine Opposite to KLE hospital Nehru Nagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439226 |
| Fax |
|
| Email |
banappau@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Kumar |
CCRAS-Central Ayurveda Research Institute Bengaluru |
Room No-13, Clinical Division, Department of Ayush, Central Ayurveda Research Institute, Bengaluru, 12, Uttarahalli Manavarthe Kaval, Uttarahalli, Thalghattapura Benglauru South, Bengaluru (Bangalore) Urban, Karnataka - 560109
Bangalore
KARNATAKA |
9784361336
rajanpaliwal25@gmail.com |
| Dr Supriya Bhalerao |
Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be) University |
OPD No-08, Department Of Obesity-Diabetes, Ground Floor, Interactive Research School for Health Affairs, Bharati Vidyapeeth (Deemed to be) University, Satara Road, Pune, Maharashtra, India. Pin code - 411046.
Pune
MAHARASHTRA |
9527589516
supriya.bhalerao@bharatividyapeeth.edu |
| Dr Mallikarjun V Jali |
KAHER- Dr Prabhakar Kore Hospital And MRC |
OPD No.5, Diabetics Centre, Kaveri Floor (Ground Floor), Nehru Nagar National Highway No.4, Belagavi-590010
Belgaum
KARNATAKA |
9844032499
drmvjali@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Ayurveda Research Institute Bengaluru |
Approved |
| Institutional Ethics Committee, Bharati Vidyapeeth Deemed University |
Approved |
| Institutional Human Ethics Committee, ICMR-National Institute of Traditional Medicine |
Approved |
| KLE University KLE Dr.PK Hospital and MRC |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala, Reference: Classical text and Salunke M, Banjare J, Bhalerao S. Effect of selected herbal formulations on anthropometry and body composition in overweight and obese individuals: randomized, double blind, placebo-controlled study. J Herb Med. 2019:17:100298, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -500 mg two tablets to be consumed two times a day before food/empty stomach with luke warm water | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo of Triphala, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: The placebo used in the study is the look-alike tablet, devoid of bio-active component “Triphala”, which is suitably coated to mask the colour, odour, and taste. |
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with abdominal/central obesity (waist circumference greater than or equal to 90 cm for men and greater than or equal to 80cm for women)
2. Individuals between 18-60 years of age.
3. Willing to participate voluntarily & gives written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. Individuals with hypothyroidism or uncontrolled thyroid disease
2. Patients who were treated with sliming drugs.
3. Pregnant and lactating women.
4. Individuals who have undergone surgery recently.
5. Patients with coronary heart disease.
6. Uncontrolled diabetes mellitus (glycosylated hemoglobin greater than 8.0 percent).
7. Patients with known malignancy, asthma, chronic cough, and psychological problems.
8. Individuals with a history of chronic kidney and liver disease.
9. History or evidence of any other condition or disease that, in the opinion of the investigator would interfere with the study evaluation, procedures, or completion
10. Patients receiving corticosteroid or immunosuppressive medications.
11. History of use one month before screening or currently using Allopathic or Ayurvedic medicines that may cause significant weight gain.
12. Active substance abuse like alcohol or drug abuse in any form or history of alcohol/drug abuse or dependence within 6 months prior to study enrolment.
13. Current participation (past one month) in an organized weight reduction program.
14. Individuals having any other medical conditions investigator(s) feel unfit to recruit.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Change in waist circumference |
Waist circumference will be measured at screening,0, 3, 6, 9, 12, and 15 months.
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Changes in Fat mass & Lean body mass (LBM)(measured by DEXA for a subset of 220 participants) |
0, 3, & 15 months |
| Changes in blood glucose (HbA1c) |
Screening/Baseline (0), 3, & 15 months |
| Lipid profile |
0, 3, & 15 months |
| Changes in Sagittal Abdominal Diameter (SAD), waist–hip ratio, body weight/BMI, & BP |
Screening,0, 3, 6, 9, 12, & 15 months |
| Changes in Resting Metabolic Rate (RMR by indirect calorimetry) |
0,3, & 15 months |
| Safety Parameters: Complete Blood Count, Liver Function Test, Renal Function Test |
Complete Blood Count (measured at 0, 3, 15 months) & Liver Function Test, Renal Function Test (measured at 0, 3 months) |
|
Target Sample Size
Modification(s)
|
Total Sample Size="880"
Sample Size from India="880"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
This is randomized; double-blind, placebo-controlled clinical trial evaluates Triphala as an add-on intervention to standard care (calorie restriction & physical activity advice as per ESI Guidelines) for Sustained Anti-obesity Effect in Central/Abdominal Obesity Adults Participants having abdominal/central obesity (waist circumference greater than or equal to 90 cm for men and greater than or equal to 80cm for women), willing to participate and provide written informed consent, will be enrolled in the study. A total of 880 participants will be randomized (1:1) into two groups: one receiving Triphala (500 mg, 2 tablets twice daily on an empty stomach for 3 months) and the other receiving a placebo (2 tablets twice daily on an empty stomach for 3 months), both along with standard care (calorie restriction & physical activity advice as per ESI Guidelines) and a subset of 220 participants (110 per group) will undergo DEXA Scan to determine the percentage of Fat change/loss. Participants will undergo assessments: Change in waist circumference, Sagittal Abdominal Diameter, waist–hip ratio, body weight/BMI, & Blood Pressure (measured at Screening,0, 3, 6, 9, 12, & 15 months), Fat Mass & LBM (measured at 0,3, & 15 months by DEXA for a subset of 220 participants), and HbA1c, Lipid profile, Resting Metabolic Rate (measured at 0,3, & 15 months), Safety parameters, including liver and renal function tests will be performed (measured at 0, and 3 month), complete blood count (measured at 0, 3, 15 months), and adverse event monitoring, will be carried out.
|