A Randomized, Double-Blind, Parallel Group Clinical Study To Evaluate Efficacy And Safety Of UO ABG 01 In The Management Of Borderline Cardio Vascular Risk Factors

Recruiting

• Conditions: Other heart disorders in diseasesclassified elsewhere,

• Registration Number: CTRI/2023/10/058501
• Lead Sponsor: Xtractiva Life Science Private Limited

Brief Summary

Rapidly growing prevalenceof cardiovascular disease is a major threat for the developed as well asdeveloping world warranting urgent need of intervention. Complementary andalternative medicines are gaining popularity among general population becauseof their safety profile and easy administration. Garlic, in particular, isconsidered one of the best disease-preventive foods because of its potent andwidespread effects. This study is to find out the role of garlic in the management of borderline cardio vascularrisk factors.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-11
• Study Start: 2023-10-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Male or female subjects between 25 to 65 years of age Ability to understand the risks/benefits of the protocol Female subjects of childbearing potential must be using a medically acceptable form of birth control.
• Female subjects of non-childbearing potential must be amenorrheic for at least 1 years or had a hysterectomy and/or bilateral oophorectomy Serum triglycerides > 115mg/dL and less than < 199 mg/dL If former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months Willing to give written informed consent and willing to comply with trial protocol.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Serum triglycerides	Day -7, Day 28, Day 56 and Day 84
• Serum HDL	Day -7, Day 28, Day 56 and Day 84
• Serum LDL	Day -7, Day 28, Day 56 and Day 84
• Total Cholesterol	Day -7, Day 28, Day 56 and Day 84
Change from Baseline to End of the study in	Day -7, Day 28, Day 56 and Day 84

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to End of the study in	• Blood Pressure

Trial Locations

Locations (1)

Chennai Meenakshi Multispeciality Hospital Limited; 🇮🇳 Chennai, TAMIL NADU, India

Chennai Meenakshi Multispeciality Hospital Limited

🇮🇳Chennai, TAMIL NADU, India

P Sudha Rani

Principal investigator

9566229193

clinsolve@gmail.com