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Clinical Trial on Patented Polyherbal Formulation for the treatment of Obesity.

Phase II clinical study of Patented antiobesity Polyherbal Formulation SJT-Ob-1

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/06/002738
Enrollment
40
Registered
2012-06-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients sufferg from Obesity and Hyperlipidemia

Interventions

Intervention1: SJT-OB-1 Capsule which contains vidang, Amla, Baheda, Harde, Piper, Ginger: two capsules to be taken thrice a day for treatment period of 75 days. Control Intervention1: Placebo: two ca

Sponsors

SJ Thakkar Pharmacy College Rajkot Gujarat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: •BMI 27-35kg/m2 •Capable of giving written informed consent •Subject with LDL-cholesterol >= 3.4 mmol/L and

Exclusion criteria

Exclusion criteria: •Subject has previous chronic diseases or surgical history •Patient with any metabolic disorders •Patients taking any medication for the obesity •Patients with an cardiac problems •Patients who did not signed the patient consent form •Subject has a history of alcohol or substance abuse or dependence prior to screening •The subject is a smoker. •Pregnant and lactating women

Design outcomes

Primary

MeasureTime frame
â?¢Reduction in body weight â?¢Reduction in cholesterol level Timepoint: â?¢Measurement of body weight and lipid profile after every 20 days of intervention

Secondary

MeasureTime frame
â?¢Duration of response is measured â?¢Safety will be assessed on the basis of adverse event monitoring, laboratory assessments, and incidence and causality of treatment delays/dose reductions/patient withdrawals due to toxicities. Timepoint: â?¢Efficacy and safety will be assessed on each visit each of after 20 days of intervention

Countries

India

Contacts

Public ContactDr Rina H Gokani

S.J Thakkar Pharmacy College

pritshikha_sis@yahoo.com9427447806

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026