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

Hyperlipidemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02100202
• Other study ID #: OLS-SH/02-14 Ver 01
• Status: Not yet recruiting
• Phase: N/A
• First received: March 22, 2014
• Last updated: March 26, 2014
• Start date: April 2014
• Est. completion date: July 2014

Study information

• Verified date: March 2014
• Source: Olive Lifesciences Pvt Ltd
• Contact: Shivaprasad H N, M Pharma, Ph.D
• Phone: 918971489704
• Email: shiv[@]olivelifesciences.com
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Chronic Smokers
• Hyperlipidemia
• Hyperlipidemias

Intervention

Other:
• Placebo

Dietary Supplement:
• BioTurmin (Curcuma longa rhizomes extract)

• BioTurmin-WD (Water dispersible curcuminoids)

• MaQxan (Tagetes erecta flower extract)

Locations

Country	Name	City	State
India	Sreenivasa Clinic Diabetic Research Center	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Olive Lifesciences Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety and tolerability (composite measure)	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	Yes
Primary	Change in urine cotinine and serum oxidative stress marker levels	nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels	Baseline and on day 30	No
Secondary	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)	Baseline and on day 30	No

External Links

•   Dietary supplements
•   Turmeric extract