Health Condition 1: E785- Hyperlipidemia, unspecified
Conditions
Interventions
Intervention1: Fish Oil + Black Seed Oil: Dose: 4 capsules a day 2 BID Dose
Dosage: 2 capsules in the morning and 2 capsules in the night after food
Treatment Duration: 3 Months
Route of Administr
Sponsors
MagGenome Technologies Pvt. Ltd
Yellow Bricks Research Hub
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects between the ages of 30 and 65 years (both ages and all genders inclusive) with hyperlipidemia (fasting triglycerides greater than or equal to 200 mg Per dL) and one other lipid parameter must be out of normal range. 2. Subjects if on lipid lowering therapy, must be stable for a minimum of 8 weeks prior to screening. 3. Subjects BMI greater than or equal to 25 at the time of screening. 4. subjects who are willing to abstain from the use of herbal, allopathic or other nutritional supplements that are indicated at improving lipid levels. 5. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
Exclusion criteria
Exclusion criteria: 1. Subjects with known allergy to seafood, shellfish, omega3, black seed oil products. 2. Subjects who are vegetarians/vegans who object to consumption of animal origin investigational product. 3. Subjects who have uncontrolled diabetes mellitus. 4. Subjects who consume alcohol on a daily basis. 5. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study. 6. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc. 7. Subjects on remission from cancer of any type less than 5 years at the time of screening 8. Subjects who are planning a pregnancy and/or currently breastfeeding. 9. Subjects who have participated in a clinical study less than 1 month before screening. 10. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol 12. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Triglycerides: Reduction of greater than or equal to 10 percentage from baseline. 2. LDL: Reduction of greater than or equal to 10 percentage from baseline. 3. HDL: Improvement of greater than or equal to 10 percentage from baseline. 4. Total Cholesterol: Reduction of greater than or equal to 10 percentage from baseline. 5. EQ 5D Health Index: Increase of greater than or equal to 50 percentage from baseline. 6. Patient Global Impressions-Improvement: Score of lesser than or equal to 3 by end of study. Timepoint: 1. Triglycerides: Day 1, Day 90 2. LDL: Day 1, Day 90 3. HDL: Day 1, Day 90 4. Total Cholesterol: Day 1, Day 90 5. EQ 5D Health Index: Day 1, Day 45, Day 90 6. Patient Global Impression: Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Yellow Bricks Research Hub (A Unit of Aurous HealthCare R&D India Pvt. Ltd.)
Outcome results
None listed