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

Primary Purpose

Chronic Smokers, Hyperlipidemia

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Placebo
BioTurmin (Curcuma longa rhizomes extract)
BioTurmin-WD (Water dispersible curcuminoids)
MaQxan
Sponsored by
Olive Lifesciences Pvt Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Smokers focused on measuring Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Sreenivasa Clinic Diabetic Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

BioTurmin

BioTurmin-WD

MaQxan

Arm Description

Capsule containing 250 mg of placebo, two times a day

Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day

Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day

Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day

Outcomes

Primary Outcome Measures

change in urine cotinine and serum oxidative stress marker (malondialdehyde) level

Secondary Outcome Measures

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)

Full Information

First Posted
July 28, 2014
Last Updated
July 28, 2014
Sponsor
Olive Lifesciences Pvt Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02203227
Brief Title
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olive Lifesciences Pvt Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Smokers, Hyperlipidemia
Keywords
Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsule containing 250 mg of placebo, two times a day
Arm Title
BioTurmin
Arm Type
Experimental
Arm Description
Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day
Arm Title
BioTurmin-WD
Arm Type
Experimental
Arm Description
Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day
Arm Title
MaQxan
Arm Type
Experimental
Arm Description
Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
BioTurmin (Curcuma longa rhizomes extract)
Intervention Type
Dietary Supplement
Intervention Name(s)
BioTurmin-WD (Water dispersible curcuminoids)
Intervention Type
Dietary Supplement
Intervention Name(s)
MaQxan
Primary Outcome Measure Information:
Title
change in urine cotinine and serum oxidative stress marker (malondialdehyde) level
Time Frame
Baseline, on day 30 and on day 60
Secondary Outcome Measure Information:
Title
Change in serum lipid profile
Description
Low density lipoprotein-cholesterol (LDL-C), very low density lipoprotein-cholesterol (VLDL-C), high density lipoprotein-cholesterol (HDL-C), total cholesterol (TC)
Time Frame
Baseline, on day 30 and on day 60
Other Pre-specified Outcome Measures:
Title
Safety and tolerability (composite measure)
Description
Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis
Time Frame
Baseline, on day 30 and on day 60

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shivaprasad H N, Ph.D
Phone
918971489704
Email
shiv@olivelifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bhanumathy M, M Pharma
Phone
919986411152
Email
bhanumathy@olivelifesciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Venkateshwarlu K, MD (Ayur)
Organizational Affiliation
Sreenivasa Clinic Diabetic Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sreenivasa Clinic Diabetic Research Center
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560050
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Venkateshwarlu K, MD (Ayur)
Phone
919945232107
Email
drvenkatesh64@gmail.com
First Name & Middle Initial & Last Name & Degree
Raveendra K, MD
Phone
919448134587
Email
drkrraveendra@gmail.com
First Name & Middle Initial & Last Name & Degree
Venkateshwarlu K, MD (Ayur)
First Name & Middle Initial & Last Name & Degree
Raveendra K, MD

12. IPD Sharing Statement

Links:
URL
http://www.nlm.nih.gov/medlineplus/dietarysupplements.html
Description
Dietary supplements
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0977052440&QV1=CURCUMA+LONGA
Description
Curcuma longa
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0090131434&QV1=TAGETES+ERECTA+EXTRACT
Description
Tagetes erecta

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

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