CTRI/2022/02/039981Not yet recruiting未知
A Randomized, Double-Blind, Parallel Group Clinical Study to evaluate Efficacy and Safety of ONLP-15 in the Management of Cardio Vascular disease risk factors
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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
Investigators
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