FindTrial
Sign In

A clinical trial to assess the Efficacy and safety of liposomal Curcumin in subjects with metabolic syndrome

A randomized, double blind, controlled clinical trial to assess the Efficacy and safety of liposomal Curcumin compared with Curcumin (non-liposomal) on inflammation in subjects with metabolic syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/06/008903
Enrollment
24
Registered
2017-06-22
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: null- Metabolic syndrome

Interventions

Intervention1: Liposomal Curcumin: strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day
Duration: 6 weeks Control Intervention1: Curcumin (Non Liposomal Curcumin): strength: 100 mg of Curcumin per 5 ml, route: Oral, Frequency: 4 times x 5mL per day
Duration: 6 weeks

Sponsors

CureSupport
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 18 years of age and above 2. Metabolic abnormalities with or without alcohol consumption and/or smoking 3. Diagnosis of MetS ie. the presence of three or more criteria of the modified National Cholesterol Education Programs Adult Treatment Panel III ( NCEP ATP III): 3.1 Waist circumference 90 cm in men and 80 cm in women 3.2 Hypertriglyceridemia >= 150 mg/dl 3.3 High density lipoprotein (HDL) cholesterol 40 mg/dl in males and 50 mg/dl in females 3.4 Blood pressure >= 130/85 mm Hg 3.5 Fasting plasma glucose >= 110 mg/dl 4.0 Patients willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding, 2. lack of compliance with the study medication (defined as not using the medication for >1 week), 3. Participation in a concomitant trial, 4. Hypersensitivity to the study medication, 5. Presence of malignancies 6. Impossibility to give informed consent. 7. Intake of drugs or dietary supplements 8. Previous illnesses such as heart attack, cancer or dementia 9. Addiction illness

Design outcomes

Primary

MeasureTime frame
Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.Timepoint: Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.—

Secondary

MeasureTime frame
Plasma tumor necrosis factor alpha at baseline and 6 weeks Plasma interleukine 6 at Baseline and 6 weeks Body weight, anthropometric assessments, Biochemistry and lipis profile assessment baseline and 6 weeks Incidence rates of adverse event and changes in vital signs Blood Hematology assessment Quality of life using SF-36 questionnaireTimepoint: Baseline (Day 0) and Day 42—

Countries

India

Contacts

Public ContactDivya Chandradhar

Bio Agile Therapeutics Pvt. Ltd.

pm@bioagiletherapeutics.com9620087715

Outcome results

None listed

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