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

NCT ID: NCT02100202

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Smokers Hyperlipidemia

Keywords

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Dietary supplements Cotinine level Malondialdehyde Chronic smokers Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Capsules containing 250 mg of placebo, two times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

BioTurmin

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

Group Type EXPERIMENTAL

BioTurmin (Curcuma longa rhizomes extract)

Intervention Type DIETARY_SUPPLEMENT

BioTurmin-WD

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

Group Type EXPERIMENTAL

BioTurmin-WD (Water dispersible curcuminoids)

Intervention Type DIETARY_SUPPLEMENT

MaQxan

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

Group Type EXPERIMENTAL

MaQxan (Tagetes erecta flower extract)

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo

Intervention Type OTHER

BioTurmin (Curcuma longa rhizomes extract)

Intervention Type DIETARY_SUPPLEMENT

BioTurmin-WD (Water dispersible curcuminoids)

Intervention Type DIETARY_SUPPLEMENT

MaQxan (Tagetes erecta flower extract)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Olive Lifesciences Pvt Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Venkateshwarlu K, MD (Ayur)

Role: PRINCIPAL_INVESTIGATOR

Sreenivasa Clinic Diabetic Research Center

Locations

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Sreenivasa Clinic Diabetic Research Center

Bangalore, Karnataka, India

Site Status

Countries

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India

Central Contacts

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Shivaprasad H N, M Pharma, Ph.D

Role: CONTACT

Phone: 918971489704

Email: [email protected]

Bhanumathy M, M Pharma

Role: CONTACT

Phone: 919986411152

Email: [email protected]

Facility Contacts

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Venkateshwarlu K, MD (Ayur)

Role: primary

Raveendra K R, MD

Role: backup

Related Links

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http://www.nlm.nih.gov/medlineplus/dietarysupplements.html

Dietary supplements

Other Identifiers

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OLS-SH/02-14 Ver 01

Identifier Type: -

Identifier Source: org_study_id