Health Condition 1: E782- Mixed hyperlipidemia
Conditions
Interventions
Intervention1: JOFP-002: JOFP-002 is a standardized 500 mg herbal capsule developed to support metabolic health through a synergistic blend of Cinnamon and Ginger extracts. It is to be taken twice dai
Sponsors
Jeeva Organic Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subjects between 18 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 Confirmed diagnosis of metabolic syndrome as per ATP-III guidelines. This includes the presence of at least 3 or more of the following 5 factors: (As per modified NCEP ATP III guidelines-specific for South Asia) Including Abdominal waist circumference greater than 90 (males), greater than 80 cm (females) and Increased blood pressure (greater than or equal to 130 per 85 mm Hg) Serum triglycerides greater than or equal to 150 mg per dL Serum HDL cholesterol less than 40 mg per dL (males), less than 50 mg per dL (females) Elevated fasting blood glucose greater than or equal to 100 mg per dL Subjects agree to maintain the activity dairy If Former smoker (previously smoked greater than or equal to 10 cigarettes per 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline to end of the study in Serum triglycerides Fasting blood glucose Timepoint: Day -7, Day 28, Day 56, Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to end of the study in Serum LDL Total Cholesterol Serum HDL Blood Pressure Abdominal waist circumference Change in Body weight Change in Glycosylated haemoglobin (HbA1c) Timepoint: Day -7, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactDr P Akash Kumar
Chennai Meenakshi Multispeciality Hospital
Outcome results
None listed