Health Condition 1: E786- Lipoprotein deficiency
Conditions
Interventions
Intervention1: Test Formulation 1: Two capsules per day for three months
Intervention2: Test Formulation 2: Two capsules per day for three months
Control Intervention1: Placebo: Two capsules per day f
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female dyslipidemic subjects aged more than or equal to 18 and less than or equal to 65 years of age 2. Appropriate BMI. 3. Subjects with history of stable weight 4. Should be positive for at least 3 CVD risk factors 5. Subject willing to comply with diet control and exercise 6. On stable antihypertensives drugs. 7. Diabetic subject who is only on oral hypoglycemic drugs 8. Must be willing to give written informed consent and comply with the study procedures 9. Female subjects are required to be non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically 10. Acceptable form of birth control, as determined by the investigator. 11. Women of child-bearing potential (non-postmenopausal and 12. Non-surgically sterilized) willing to undergo a urine pregnancy test 13. Subject meeting all the laboratory parameters set forth to qualify to enroll in the study
Exclusion criteria
Exclusion criteria: 1. Subject with very high values of blood lipids and glucose. 2. Type 1 diabetes mellitus or secondary diabetes mellitus 3. History of coronary artery disease (CAD), Angina, tread mill test 4. (TMT) positive for inducible ischemia 5. Uncontrolled hypertension 6. Subjects on medications which might alter blood lipid levels. 7. Other therapies such as homeopathy / ayurveda etc for treating above mentioned conditions 8. Subjects who are allergic to herbal products or any component of the study product 9. Pregnant or lactating women 10. Subject with any abnormal/altered absorption or digestion. 11. Suffering from any condition which in opinion of the Investigator may interfere with nutrient absorption, distribution, metabolism and excretion. 12. Subject with deteriorating health status at the time of enrollment. 13. Known HIV positive. (e.g., human immunodeficiency virus [HIV] infection) or any other immuno-compromised state by history 14. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 15. Abnormal LFT and RFT. 16. Subject unwilling or unable to comply with the study procedures 17. History of allergy to any component of the study product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of test capsules in comparison with placebo for management of cardiovascular health (CVH) risk factors (change in lipid profile) in dyslipidemic adults.Timepoint: Months 1, 2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the efficacy of test capsules in comparison with placebo for improving the levels of high sensitivity C reactive protein, serum fasting insulin, fasting and post prandial blood sugar (FBS and PPBS), HbA1c, apolipoprotein B, blood pressure (BP), body mass index (BMI), body fat percentage and waist /hip circumferenceTimepoint: Months 1, 2 and 3 | — |
Countries
India
Contacts
Public ContactMr Vijay Bhaskar
NextBio Research Pvt Ltd
Outcome results
None listed