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Trial record 37 of 108 for:    Turmeric extract | Turmeric

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

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ClinicalTrials.gov Identifier: NCT02100202
Recruitment Status : Unknown
Verified March 2014 by Olive Lifesciences Pvt Ltd.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Olive Lifesciences Pvt Ltd

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.

Condition or disease Intervention/treatment Phase
Chronic Smokers Hyperlipidemia Other: Placebo Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract) Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids) Dietary Supplement: MaQxan (Tagetes erecta flower extract) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : April 2014
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100202


Contacts
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Contact: Shivaprasad H N, M Pharma, Ph.D 918971489704 shiv@olivelifesciences.com
Contact: Bhanumathy M, M Pharma 919986411152 bhanumathy@olivelifesciences.com

Locations
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India
Sreenivasa Clinic Diabetic Research Center Not yet recruiting
Bangalore, Karnataka, India, 560050
Contact: Venkateshwarlu K, MD (Ayur)    919945232107    drvenkatesh64@gmail.com   
Contact: Raveendra K R, MD    919448134587    drkrraveendra@gmail.com   
Sub-Investigator: Raveendra K R, MD         
Principal Investigator: Venkateshwarlu K, MD         
Sponsors and Collaborators
Olive Lifesciences Pvt Ltd
Investigators
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Principal Investigator: Venkateshwarlu K, MD (Ayur) Sreenivasa Clinic Diabetic Research Center

Additional Information:
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Responsible Party: Olive Lifesciences Pvt Ltd
ClinicalTrials.gov Identifier: NCT02100202     History of Changes
Other Study ID Numbers: OLS-SH/02-14 Ver 01
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014
Keywords provided by Olive Lifesciences Pvt Ltd:
Dietary supplements
Cotinine level
Malondialdehyde
Chronic smokers
Hyperlipidemia
Additional relevant MeSH terms:
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Hyperlipidemias
Hyperlipoproteinemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs