Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia

March 26, 2014 updated by: Olive Lifesciences Pvt Ltd

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560050
        • Sreenivasa Clinic Diabetic Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Capsules containing 250 mg of placebo, two times a day
Other: Placebo
Experimental: BioTurmin
Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day
Dietary supplement: BioTurmin (Curcuma longa rhizomes extract)
Experimental: BioTurmin-WD
Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day
Dietary supplement: BioTurmin-WD (Water dispersible curcuminoids)
Experimental: MaQxan
Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day
Dietary supplement: MaQxan (Tagetes erecta flower extract)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urine cotinine and serum oxidative stress marker levels
Time Frame: Baseline and on day 30
nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels
Baseline and on day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum lipid profile
Time Frame: Baseline and on day 30
Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)
Baseline and on day 30

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability (composite measure)
Time Frame: Baseline and on day 30
Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis
Baseline and on day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olive Lifesciences Pvt Ltd

Investigators

  • Principal Investigator: Venkateshwarlu K, MD (Ayur), Sreenivasa Clinic Diabetic Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

March 22, 2014

First Submitted That Met QC Criteria

March 26, 2014

First Posted (Estimate)

March 31, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2014

Last Update Submitted That Met QC Criteria

March 26, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OLS-SH/02-14 Ver 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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