Ayurvedic treatment for Metabolic Syndrome a disease which includes obesity, elevated blood pressure, abnormal lipids with early diabetes at one place

Phase 3

Recruiting

• Conditions: Metabolic syndrome

• Registration Number: CTRI/2015/06/005899
• Lead Sponsor: Adesh University

Brief Summary

A randomized double blinded conventionalcontrolled clinical trial shall be carried out to validate the beneficial roleof novel poly-herbal formulation beneficial in the prevention of cardiovasculardisorders among metabolic syndrome patients. The age range of metabolicsyndrome will be 40-70 years of both the gender. The modern conventional agent **Orlistat** shall be used for controldesign. The biological potential of test formulation will be evaluated on theassociated markers with metabolic syndrome as described earlier. Minimum 1000patients of metabolic syndrome shall be included in the clinical trial and willbe followed up for a period of 1 year. The advanced statistical method will beapplied to establish the beneficial role of test formulation in the preventionand management of metabolic syndrome and associated cardiovascular riskfactors.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-01
• Last Update Posted: 2015-02-13

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Triglycerides>150 mg% 2.
• Abdominal girth Male > 102 cm and Female > 85 cm 3.
• HDL < 40 mg% in Male and < 50 mg% in Female 5.
• Fasting Blood Sugar > 100 mg%.

Exclusion Criteria

• FBS <100 mg% 2.
• TG <150 mg% 3.
• BP Systolic < 130 mmHg and Diastolic <85mmHg.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of Ayurvedic formulation on body mass index, lipid profile, blood pressure, leptin and adiponectin level.	A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment.

Secondary Outcome Measures

Name	Time	Method
Modified atherogenic dyslipidemia along with improvement in feeling of well being and work performance was noticed.	A gradual improvement was noticed in the abnormalities associated with metabolic syndrome. The most effective results were obtained at the end of six months of treatment.

Trial Locations

Locations (1)

Adesh University; 🇮🇳 Bathinda, PUNJAB, India

Adesh University

🇮🇳Bathinda, PUNJAB, India

Dr G P I Singh

Principal investigator

9815542987

gpisingh.dr@gmail.com