Health Condition 1: null- chronic smokers
Conditions
Interventions
Intervention1: BioTurmin (Curcuma longa standardized extract): 250 mg capsule taken orally after food
twice daily (500 mg/day) for 60 days
Intervention2: BioTurmin-WD (Curcuma longa water dispersible extract): 250 mg capsule taken orally after food
twice daily (500 mg/day) for 60 days
Intervention3: MaQxan (Tagetes erecta flower extract): 250 mg capsule taken orally after food
twice daily (20 mg/day) for 60 days
Control Intervention1: Placebo: 250 mg capsule taken orally after food
twice daily for 60 days
Sponsors
Olive Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Men >20 years. Chronic cigarette/ beedi smoker (2-3 packets/day since last 3 years or more) with mild to moderate hyperlipidemia (LDL ranging 160-189 mg/dL, TC >200 mg/dL and/or HDL-C Being mentally competent and able to understand all study requirements and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients with Chronic obstructive pulmonary disease (COPD). Women. Patients with severe liver, renal, cardiac or brain diseases. Unable to complete follow up. Subjects on any medication like diuretics. Allergic to any medication. With a history of alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in urine cotinine and serum oxidative stress marker (malondialdehyde) levelTimepoint: Baseline, on day 30 and 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in serum lipid profileTimepoint: Baseline, on day 30 and 60;Safety and tolerability [physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology (CBC), biochemical tests (serum urea, serum creatinine), liver function test and urine analysis].Timepoint: Baseline, on day 30 and 60 | — |
Countries
India
Contacts
Public ContactDr HN Shivaprasad
Olive Lifesciences Pvt Ltd
Outcome results
None listed