A Randomized, Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors

Not yet recruiting

• Conditions: Endocrine, nutritional and metabolic diseases,

• Registration Number: CTRI/2022/02/039981
• Lead Sponsor: Olene Life Sciences Private Limited

Brief Summary

Rapidly growing prevalence of cardiovascular disease is a major threat for the developed as well as developing world warranting urgent need of intervention. Complementary and alternative medicines are gaining popularity among general population because of their safety profile and easy administration. Garlic, in particular, is considered to be one of the best disease-preventive foods because of its potent and widespread effects. This study is to find out the role of garlic in cardiovascular disease prevention.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-01-02
• Study Start: 2022-10-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 1 Male or female subjects between 30 to 65 years of age 2 Ability to understand the risks benefits of the protocol 3 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 4 Serum triglycerides > 115mg/dL and less than < 199 mg/dL 5 If Former smoker (previously smoked ≥10 cigarettes/day for at least 1 year, cessation for at least 6 months 6 Willing to give written informed consent and willing to comply with trial protocol.

Exclusion Criteria

Pregnant or breast feeding women Serum glucose levels higher than 126 mg/dL Use of cholesterol lowering medication or supplements Use of blood pressure lowering medication Subjects having abnormal liver or kidney function tests ALT or AST more than 2 times the upper limit of normal elevated Creatinine, males more than 125 μmol per L females more than 110 μmol per L renal insufficiency thyroid or other endocrine disease Any other condition that, in the opinion of the investigator would adversely affect the subject s ability to complete the study or its measures Hypersensitivity to any of the ingredient used in the study supplements Alcohol consumption exceeding the definition of moderate drinking 2 drinks per day for men or 1 drink per day for women Subjects participated in any investigational study medication within thirty days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline to End of the study in	Day 0 Day 28 Day 56 Day 84
Serum triglycerides	Day 0 Day 28 Day 56 Day 84
Serum LDL	Day 0 Day 28 Day 56 Day 84
Serum HDL cholesterol	Day 0 Day 28 Day 56 Day 84
Total Cholesterol	Day 0 Day 28 Day 56 Day 84

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hycare Super Specialty Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Hycare Super Specialty Hospital

🇮🇳Chennai, TAMIL NADU, India

Dr T Mohanasundaram

Principal investigator

04423637700

moins1996@gmail.com