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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02203227 |
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Date of registration:
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28/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
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Scientific title:
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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 |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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60 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02203227 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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India
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Contacts
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Name:
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Venkateshwarlu K, MD (Ayur) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sreenivasa Clinic Diabetic Research Center |
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Name:
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Shivaprasad H N, Ph.D |
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Address:
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Telephone:
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918971489704 |
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Email:
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shiv@olivelifesciences.com |
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Affiliation:
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Name:
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Venkateshwarlu K, MD (Ayur) |
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Address:
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Telephone:
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919945232107 |
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Email:
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drvenkatesh64@gmail.com |
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Affiliation:
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Key inclusion & exclusion 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.
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Chronic Smokers
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Hyperlipidemia
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Intervention(s)
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Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)
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Dietary Supplement: Placebo
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Dietary Supplement: MaQxan
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Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)
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Primary Outcome(s)
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change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
[Time Frame: Baseline, on day 30 and on day 60]
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Secondary Outcome(s)
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Change in serum lipid profile
[Time Frame: Baseline, on day 30 and on day 60]
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Secondary ID(s)
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OLS-SH/06-14 VER 01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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