A clinical study on PALATTIRIKKATI CURANAM in the management of Atitulam (Obesity)

Phase 2

Recruiting

• Conditions: Obesity, unspecified,

• Registration Number: CTRI/2020/05/025001
• Lead Sponsor: GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL

Brief Summary

**This study is an Open Labelled Phase II Non-Randomized Clinical Control Study to evaluate the therapeutic effect of PALATTIRIKKATI CURANAM in the management of ATITULAM****(Obesity). The trial drug will be administrated at the dose 2g  twice a day after meals for 90 days in 60 patients. The trial period will be carried out at Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamil Nadu - 627002. The primary outcome will be to evaluate the therapeutic effect of the Trial Drug in the management of Atitulam. Secondary outcome will be the assessment of safety profile, pharmacological and biochemical parameters of trial drug. In case of any adverse effect is noted it will be reffered to the pharmacovigillence department of SCRI. Futher management for the patients will be given in OPD facility.**

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-05
• Last Update Posted: 2020-06-15

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

BMI- More than 27 up to 35 WHR- More than 0.85 up to 1.00 Diagnosed Hypertension, Diabetes Mellitus.

Exclusion Criteria

• age below 20 and above 65 BMI.
• Below 27 & above 35 WHR.
• Below 0.85 & above 1.00 Renal Diseases Endocrine diseases Familial obesity Pregnancy Lactating mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weight and complains reduction during treatment or after treatment	weight and complains reduction during treatment or after treatment

Secondary Outcome Measures

Name	Time	Method
Find the pre clinical study of the trial drug.	To find out the cost effectiveness of the trial drug

Trial Locations

Locations (1)

GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL; 🇮🇳 Tirunelveli, TAMIL NADU, India

GOVERNMENT SIDDHA MEDICAL COLLEGE AND HOSPITAL

🇮🇳Tirunelveli, TAMIL NADU, India

ROSALYN SHOBANAA MATHIVATHANAN

Principal investigator

7339203756

rosalyn.shobanaa@gmail.com