To study the effect of 3 different formulations of curcumin (Any one of the 3 curcumin formulations - 1.CONVENTIONAL, 2.SELF NANO EMULSIFYING, AND 3. With PIPERINE FORMULATION) taken as add-on therapy for a period of 90 days in Hyperlipidemic patients on the levels of Lipid profile.
- Conditions
- Health Condition 1: E70-E88- Metabolic disordersHealth Condition 2: E780- Pure hypercholesterolemia
- Registration Number
- CTRI/2018/09/015714
- Lead Sponsor
- Self Sponsored
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient able to provide written informed consent
2. Patient of either sex of age 20 - 60 years (Both included)
3. Diagnosed with Hyperlipidemia.
4. Patient on Anti-hyperlipidemic drugs for at least 1 year.
1. Participants allergic /Sensitive to Turmeric, Curcumin or any of its derivative.
2. Patient with very high Cholesterol level ( > 300 mg/dl)
3. Patients diagnosed with a Cardiovascular disease.
4. Patients diagnosed with Brain Tumors, Dementia, Depression, Parkinsonâ??s disease
5. Concomitant treatment with other antidepressants, psychostimulants, or mood stabilizers, antiepileptic and antipsychotics.
6. Presence of illicit drug and/or alcohol dependence.
7. Pregnancy.
8. Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain) and congenital disorders.
9. Malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease) or lead poisoning.
10. Chronic use of drugs affecting metabolism rate. (e.g., oral corticosteroids).
11. Acute and Chronic Renal failure, hepatic disease, Stomach Ulcers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Study and evaluate the variations in the level of Lipid profile (Particularly in HDL levels) before and after administration of three different drug molecules (1.Conventional Curcumin, 2.Self Nano emulsifying Curcumin, and 3.Curcumin with Piperine formulation) with a control/ placebo drug for a period of 90 days taken as an add-on treatment in a total of 88 Hyperlipidemic patients (22 in each group) and to study the mechanism of action of Curcumin in reaching the outcome.Timepoint: The data shall be evaluated after 90 days after the start of the administration of any one of the three different drug formulation of Curcumin (1.Conventional, 2.Self Nano emulsifying, & 3.With Piperine) with a control/ placebo drug. in 88 Hyperlipidemic patients (22 in each group)
- Secondary Outcome Measures
Name Time Method To monitor the adverse evnts reported during the entire course of the study.Timepoint: 30 days from the last day of the trial.