A Study to Evaluate the Effect of Triphala Along with Standard Care for Sustained Anti-obesity Effect in Central Obesity Adults.

Evaluation of Triphala as an Add-on Intervention for Sustained Anti-obesity Effect in Central Obesity: A Randomized Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085727

Enrollment

880

Registered

2025-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E66- Overweight and obesity

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Secondary

Measure	Time frame
Changes in Fat mass & Lean body mass (LBM)(measured by DEXA for a subset of 220 participants)Timepoint: 0, 3, & 15 months;Changes in blood glucose (HbA1c)Timepoint: Screening/Baseline (0), 3, & 15 months;Lipid profileTimepoint: 0, 3, & 15 months;Changes in Sagittal Abdominal Diameter (SAD), waistâ??hip ratio, body weight/BMI, & BPTimepoint: Screening,0, 3, 6, 9, 12, & 15 months;Changes in Resting Metabolic Rate (RMR by indirect calorimetry)Timepoint: 0,3, & 15 months;Safety Parameters: Complete Blood Count, Liver Function Test, Renal Function TestTimepoint: Complete Blood Count (measured at 0, 3, 15 months) & Liver Function Test, Renal Function Test (measured at 0, 3 months)	—

Measure

Time frame

Changes in Fat mass & Lean body mass (LBM)(measured by DEXA for a subset of 220 participants)Timepoint: 0, 3, & 15 months;Changes in blood glucose (HbA1c)Timepoint: Screening/Baseline (0), 3, & 15 months;Lipid profileTimepoint: 0, 3, & 15 months;Changes in Sagittal Abdominal Diameter (SAD), waistâ??hip ratio, body weight/BMI, & BPTimepoint: Screening,0, 3, 6, 9, 12, & 15 months;Changes in Resting Metabolic Rate (RMR by indirect calorimetry)Timepoint: 0,3, & 15 months;Safety Parameters: Complete Blood Count, Liver Function Test, Renal Function TestTimepoint: Complete Blood Count (measured at 0, 3, 15 months) & Liver Function Test, Renal Function Test (measured at 0, 3 months)

—

Primary

Measure	Time frame
Change in waist circumferenceTimepoint: Waist circumference will be measured at screening,0, 3, 6, 9, 12, and 15 months.	—

Countries

India

Contacts

Public ContactDr Banappa S Unger

ICMR National Institute of Traditional Medicine

barvaliya.m@icmr.gov.in08312475477

Outcome results