Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Vestige Flax Oil capsules: One Capsule to be taken 3 times a day orally after meals.
Control Intervention1: NIL: NIL
Sponsors
Vestige Marketing Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is willing and able to give written informed consent. 2. Female subjects aged = 18 and = 65 years 3. The subjects will be considered to have dyslipidemia if they met 2 of the following 4 criteria: • fasting total cholesterol concentration >200 mg/dL, • fasting triglyceride concentration >150mg/dL, • fasting LDL-cholesterol concentrations >100 mg/dL, or • fasting HDL-cholesterol concentrations >40 mg/dL. 4. Patients who are taking lipid lowering drugs should continue the same dosage during the study. 5. Subject is willing, able, and likely to comply with all study procedures and restrictions.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism. 2. Subjects who have used any antioxidant such as Vitamin E, vitamin C, Phytochemicals, and coenzyme Q10 within two months before trial. 3. Pregnant or lactating women 4. Patients with Homozygous Familial Hypercholesterolemia 5. AST or ALT level increases at least twice the upper limits of normal in patients 6. Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial. 7. Any other condition that in the investigator’s judgment might interfere with study objectives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Mean change in Low-Density Lipoprotein (LDL-C) from baseline to end of the study.Timepoint: Day 0 to Day 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Mean change in Total Cholesterol Concentration from baseline to end of the study. • Mean change in High-Density Lipoprotein (HDL-C) from baseline to end of the study. • Mean change in Triglyceride concentration (TG) from baseline to end of the study. • Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study. Timepoint: Day 0 to Day 56 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd
Outcome results
None listed