Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
July 29, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJuly 29, 2014
July 1, 2014
6 months
July 28, 2014
July 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
Baseline, on day 30 and on day 60
Secondary Outcomes (1)
Change in serum lipid profile
Baseline, on day 30 and on day 60
Other Outcomes (1)
Safety and tolerability (composite measure)
Baseline, on day 30 and on day 60
Study Arms (4)
Placebo
PLACEBO COMPARATORCapsule containing 250 mg of placebo, two times a day
BioTurmin
EXPERIMENTALCapsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day
BioTurmin-WD
EXPERIMENTALCapsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day
MaQxan
EXPERIMENTALCapsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sreenivasa Clinic Diabetic Research Center
Bangalore, Karnataka, 560050, India
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Venkateshwarlu K, MD (Ayur)
Sreenivasa Clinic Diabetic Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2014
First Posted
July 29, 2014
Study Start
August 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
July 29, 2014
Record last verified: 2014-07