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

Primary Purpose

Chronic Smokers, Hyperlipidemia

Status

Unknown status

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Placebo

BioTurmin (Curcuma longa rhizomes extract)

BioTurmin-WD (Water dispersible curcuminoids)

MaQxan (Tagetes erecta flower extract)

About this trial

This is an interventional prevention trial for Chronic Smokers focused on measuring Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Sreenivasa Clinic Diabetic Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BioTurmin

BioTurmin-WD

MaQxan

Arm Description

Capsules containing 250 mg of placebo, two times a day

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

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

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

Outcomes

Primary Outcome Measures

Change in urine cotinine and serum oxidative stress marker levels

nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels

Secondary Outcome Measures

Change in serum lipid profile

Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)

Full Information

NCT ID

NCT02100202

First Posted

March 22, 2014

Last Updated

March 26, 2014

Sponsor

Olive Lifesciences Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02100202

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

July 2014 (Anticipated)

Study Completion Date

July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olive Lifesciences Pvt Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Smokers, Hyperlipidemia

Keywords

Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Capsules containing 250 mg of placebo, two times a day

Arm Title

BioTurmin

Arm Type

Experimental

Arm Description

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

Arm Title

BioTurmin-WD

Arm Type

Experimental

Arm Description

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

Arm Title

MaQxan

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Type

Dietary Supplement

Intervention Name(s)

BioTurmin (Curcuma longa rhizomes extract)

Intervention Type

Dietary Supplement

Intervention Name(s)

BioTurmin-WD (Water dispersible curcuminoids)

Intervention Type

Dietary Supplement

Intervention Name(s)

MaQxan (Tagetes erecta flower extract)

Primary Outcome Measure Information:

Title

Change in urine cotinine and serum oxidative stress marker levels

Description

nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels

Time Frame

Baseline and on day 30

Secondary Outcome Measure Information:

Title

Change in serum lipid profile

Description

Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)

Time Frame

Baseline and on day 30

Other Pre-specified Outcome Measures:

Title

Safety and tolerability (composite measure)

Description

Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis

Time Frame

Baseline and on day 30

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shivaprasad H N, M Pharma, Ph.D

Phone

918971489704

shiv@olivelifesciences.com

First Name & Middle Initial & Last Name or Official Title & Degree

Bhanumathy M, M Pharma

Phone

919986411152

bhanumathy@olivelifesciences.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Venkateshwarlu K, MD (Ayur)

Organizational Affiliation

Sreenivasa Clinic Diabetic Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sreenivasa Clinic Diabetic Research Center

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560050

Country

India

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Venkateshwarlu K, MD (Ayur)

Phone

919945232107

drvenkatesh64@gmail.com

First Name & Middle Initial & Last Name & Degree

Raveendra K R, MD

Phone

919448134587

drkrraveendra@gmail.com

First Name & Middle Initial & Last Name & Degree

Raveendra K R, MD

First Name & Middle Initial & Last Name & Degree

Venkateshwarlu K, MD

12. IPD Sharing Statement

Links:

URL

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

Description

Dietary supplements

Learn more about this trial

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

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