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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02203227

Enrollment

Registered

2014-07-29

Start date

2014-08-31

Completion date

2015-02-28

Last updated

2014-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Smokers, Hyperlipidemia

Keywords

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

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 and 60 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 60 days. The efficacy of the supplements will be measured by estimating cotinine and malondialdehyde level.

Interventions

DIETARY_SUPPLEMENTBioTurmin-WD (Water dispersible curcuminoids)

DIETARY_SUPPLEMENTMaQxan

DIETARY_SUPPLEMENTPlacebo

DIETARY_SUPPLEMENTBioTurmin (Curcuma longa rhizomes extract)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
change in urine cotinine and serum oxidative stress marker (malondialdehyde) level	Baseline, on day 30 and on day 60

Secondary

Measure	Time frame	Description
Change in serum lipid profile	Baseline, on day 30 and on day 60	Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)

Other

Measure	Time frame	Description
Safety and tolerability (composite measure)	Baseline, on day 30 and on day 60	Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology \[complete blood count (CBC)\], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis

Countries

India

Contacts

Primary ContactShivaprasad H N, Ph.D

shiv@olivelifesciences.com918971489704

Backup ContactBhanumathy M, M Pharma

bhanumathy@olivelifesciences.com919986411152

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026