A study to evaluate if siddha medicine can help reduce weight and body measurements in people with moderate obesity

Phase 2/3

Not yet recruiting

Conditions: Obesity, unspecified,

Registration Number: CTRI/2025/06/088981

Lead Sponsor: National Institute of Siddha

Brief Summary: This open-labelled, single-centric, prospective clinical trial aims to evaluate the therapeutic efficacy of a Siddha regimen (Karunjeeraga Chooranam, Kukil parpam tablet, Naththaichoori chooranam) at Ayothidoss Pandithar Hospital Chennai, in managing Class 1 and 2 obesity. Participants aged between 18 and 60 years with a BMI greater than or equal to 30 kg/m², who meet the specified inclusion and exclusion criteria, will be enrolled in the trial. They will receive the trial regimen for an initial period of 48 days, followed by a 7-day drug-free interval, and then continue the regimen for an additional 48 days. The primary objective is to achieve a 5-10% reduction in BMI and anthropometric measurements, while secondary objectives include assessing changes in laboratory parameters and quality of life. The study excludes vulnerable groups, hypothyroidism, and malignancy, aiming to provide evidence on the efficacy of Siddha medicine in obesity management.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

K/C/O Diabetes Mellitus Obesity – BMI greater than or equal to 30 kg/m^2 Obesity class I – BMI 30 to 34.9 kg/m^2 Obesity class II – BMI 35 to 39.9 kg/m^2.

Exclusion Criteria

Vulnerable groups (Pregnancy and lactation) Hypothyroidism Malignancy The patient is not willing to undergo laboratory investigations.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
baseline to endpoint	103 days
A 5 to 10 percent reduction in BMI and a reduction in anthropometric measurements from	103 days

Secondary Outcome Measures

Name	Time	Method
To assess the difference in laboratory parameters and Enhanced Quality of Life from	baseline to endpoint

Trial Locations

Locations (1): Ayothidoss Pandithar Hospital
🇮🇳
Chennai, TAMIL NADU, India
Ayothidoss Pandithar Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr G Senthilvel
Principal investigator
siddha.senthilvel@gmail.com