Health Condition 1: I688- Other cerebrovascular disorders indiseases classified elsewhere
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male or female participants; Mild to moderate cardiometabolic risk factors including borderline dyslipidemia, prehypertension and overweight; CBC, LFT, and RFT within clinically acceptable ranges; Women with negative pregnancy test; Willingness to comply with study protocol
Exclusion criteria
Exclusion criteria: Known cardiovascular diseases like MI, stroke, heart failure; Uncontrolled hypertension or diabetes; Current use of lipid-lowering, antihypertensive, or anti-inflammatory drugs; Known liver, kidney, or hematological disorders History of hypersensitivity to any ingredient of the study product; Participation in another clinical trial; Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Total cholesterol, LDL cholesterol, HDL cholesterol, and Triglycerides, Blood Pressure and Serum C-reactive protein (CRP) levelsTimepoint: Change from Screening to Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in resting 12-lead ECG parameters, exercise tolerance and ECG response during Treadmill Test (TMT), Body Mass Index (BMI) and fasting blood glucose levels, physical activity level, sleep quality, laboratory safety parameters (CBC, LFT, RFT), incidence and severity of adverse events Timepoint: Change from Baseline to Day 60 | — |
Countries
India
Contacts
BIORADIAN LIFESCIENCE