Chronic SmokersNCT02100202
Efficacy and Safety Study of Dietary Supplements in Chronic Smokers Having Mild to Moderate Hyperlipidemia
A study testing BioTurmin (Curcuma longa rhizomes extract), BioTurmin-WD (Water dispersible curcuminoids) and MaQxan (Tagetes erecta flower extract) in people with Chronic Smokers and Hyperlipidemia, run by Olive Lifesciences Pvt Ltd at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Chronic Smokers, Hyperlipidemia
- What is being tested?
- BioTurmin (Curcuma longa rhizomes extract), BioTurmin-WD (Water dispersible curcuminoids) and MaQxan (Tagetes erecta flower extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Sreenivasa Clinic Diabetic Research Center
Bangalore, Karnataka, 560050
Venkateshwarlu K, MD (Ayur), 919945232107, drvenkatesh64@gmail.com
Raveendra K R, MD, 919448134587, drkrraveendra@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Chronic Smokers, Hyperlipidemia
- Being tested
- Placebo, BioTurmin (Curcuma longa rhizomes extract), BioTurmin-WD (Water dispersible curcuminoids), MaQxan (Tagetes erecta flower extract)
- Keywords
- Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
BioTurmin (Curcuma longa rhizomes extract)Dietary supplement
BioTurmin-WD (Water dispersible curcuminoids)Dietary supplement
MaQxan (Tagetes erecta flower extract)Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules containing 250 mg of placebo, two times a day Receives: Other: Placebo |
| BioTurmin | Experimental | Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day Receives: Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract) |
| BioTurmin-WD | Experimental | Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day Receives: Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids) |
| MaQxan | Experimental | Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day Receives: Dietary Supplement: MaQxan (Tagetes erecta flower extract) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urine cotinine and serum oxidative stress marker levels
nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels
Measured: Baseline and on day 30
Secondary outcomes (1)
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)
Measured: Baseline and on day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olive Lifesciences Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Venkateshwarlu K, MD (Ayur), Principal investigator, Sreenivasa Clinic Diabetic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100202
- Sponsor's protocol ID
- OLS-SH/02-14 Ver 01
- Status last verified
- Mar 2014
- First submitted
- 22 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02100202
- Acronym / sponsor ID
- OLS-SH/02-14 Ver 01
- Conditions
- Chronic Smokers, Hyperlipidemia
- Keywords
- Dietary supplements, Cotinine level, Malondialdehyde, Chronic smokers, Hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Olive Lifesciences Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 31 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboCapsules containing 250 mg of placebo, two times a day |
| BioTurmin | Experimental | Dietary Supplement: BioTurmin (Curcuma longa rhizomes extract)Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day |
| BioTurmin-WD | Experimental | Dietary Supplement: BioTurmin-WD (Water dispersible curcuminoids)Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day |
| MaQxan | Experimental | Dietary Supplement: MaQxan (Tagetes erecta flower extract)Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo | Other | Placebo |
| BioTurmin (Curcuma longa rhizomes extract) | Dietary supplement | BioTurmin |
| BioTurmin-WD (Water dispersible curcuminoids) | Dietary supplement | BioTurmin-WD |
| MaQxan (Tagetes erecta flower extract) | Dietary supplement | MaQxan |
Primary outcome
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
1 secondary outcome
Change in serum lipid profile
Time frame: Baseline and on day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
- Dietary supplementsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Venkateshwarlu K, MD (Ayur) principal investigator
Sreenivasa Clinic Diabetic Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioTurmin (Curcuma longa rhizomes extract), BioTurmin-WD (Water dispersible curcuminoids) and MaQxan (Tagetes erecta flower extract) in people with Chronic Smokers and Hyperlipidemia, run by Olive Lifesciences Pvt Ltd at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shivaprasad H N, M Pharma, Ph.D (918971489704, shiv@olivelifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urine cotinine and serum oxidative stress marker levels (time frame: Baseline and on day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.