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.

A randomised placebo control comparative study of 3 Curcumin formulations (1.Conventional Curcumin, 2.Self Nano emulsifying Curcumin, and 3.Curcumin with Piperine formulation) as an Add-on therapy in Hyperlipidemic human patients and evaluating their effect on the Lipid profile.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/09/015714

Enrollment

Registered

2018-09-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E70-E88- Metabolic disorders Health Condition 2: E780- Pure hypercholesterolemia

Interventions

Intervention1: 1.Conventional Curcumin 2.Self Nano emulsifying Curcumin 3.Curcumin with Piperine 4.Placebo molecule: 22 subjects in each group shall be administered the investigational product as per

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
To monitor the adverse evnts reported during the entire course of the study.Timepoint: 30 days from the last day of the trial.	—

Countries

India

Contacts

Public ContactDr Prem Kapur

HAKEEM ABDUL HAMEED CENTENARY (HAHC) HOSPITAL

pkapoor@jamiahamdard.ac.in01126059671

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026