Trial | NCT02100202  Report issue

Title

Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
Efficacy and Safety Study of Dietary Supplements (BioTurmin, BioTurmin-WD and MaQxan) on Cotinine Level and Oxidative Stress Marker in Chronic Smokers Having Mild to Moderate Hyperlipidemia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
The purpose of this study is to investigate the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) on cotinine level and oxidative stress marker in chronic smokers having mild to moderate hyperlipidemia after 30 days of intervention.
In a randomized, double-blind, placebo control trial, the efficacy and safety of dietary supplements (BioTurmin, BioTurmin-WD and MaQxan) will be investigated in chronic smokers having mild to moderate hyperlipidemia. Sixty subjects will be randomly assigned to receive the dietary supplements and placebo for 30 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.
Study Started
Apr 30
2014
Primary Completion
Jul 31
2014
Anticipated
Study Completion
Jul 31
2014
Anticipated
Last Update
Mar 31
2014
Estimate

Dietary Supplement MaQxan (Tagetes erecta flower extract)

Dietary Supplement BioTurmin-WD (Water dispersible curcuminoids)

Other Placebo

Dietary Supplement BioTurmin (Curcuma longa rhizomes extract)

Placebo Placebo Comparator

Capsules containing 250 mg of placebo, two times a day

BioTurmin Experimental

Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day

BioTurmin-WD Experimental

Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day

MaQxan Experimental

Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day

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 <40 mg/dL)

Being mentally competent and able to understand all study requirements and sign the informed consent form.

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.
No Results Posted