A clinical trial to assess the Efficacy and safety of liposomal Curcumin in subjects with metabolic syndrome
Active, not recruiting
- Conditions
- Metabolic syndrome
- Registration Number
- CTRI/2017/06/008903
- Lead Sponsor
- CureSupport
- Brief Summary
The purpose of the study is to investigate the liposomal curcumin efficacy and safety on inflammatory markers, lipid profile, blood glucose etc. in patients with metabolic syndrome. Liposomal curcumin product has been encapsulated inliposomes. Liposomes are small lipid globules that are created naturally whenwater is mixed with lecithin, an ingredient of soy beans. Liposomes are readilyabsorbed by the body. When Liposomal Cureit curcumin is mixed with lecithin itis encapsulated by the liposomes. The result is an improved absorption ofcurcumin in the blood.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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
- 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.
- Intake of drugs or dietary supplements 8.
- Previous illnesses such as heart attack, cancer or dementia 9.
- Addiction illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks. Inflammatory marker C-reactive protein (CRP) at baseline and 6 weeks.
- Secondary Outcome Measures
Name Time Method Plasma tumor necrosis factor alpha at baseline and 6 weeks Plasma interleukine 6 at Baseline and 6 weeks
Trial Locations
- Locations (1)
Pristine Hospital and Research Centre Pvt Ltd.
🇮🇳Bangalore, KARNATAKA, India
Pristine Hospital and Research Centre Pvt Ltd.🇮🇳Bangalore, KARNATAKA, IndiaDr Shivaraj K KPrincipal investigator9035209089shivarajkk09@gmail.com