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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsules containing 250 mg of placebo, two times a day |
|
| BioTurmin | Experimental | Capsules containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day |
|
| BioTurmin-WD | Experimental | Capsules containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day |
|
| MaQxan | Experimental | Capsules containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other |
| ||
| BioTurmin (Curcuma longa rhizomes extract) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in urine cotinine and serum oxidative stress marker levels | nicotine metabolite (cotinine) and serum oxidative stress marker (malondialdehyde) levels | Baseline and on day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and on day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (composite measure) | Physical and clinical laboratory evaluations - Electrocardiogram (ECG), haematology [complete blood count (CBC)], biochemical tests (serum urea, serum creatinine), liver function test and urine analysis | Baseline and on day 30 |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivaprasad H N, M Pharma, Ph.D | Contact | 918971489704 | shiv@olivelifesciences.com | |
| Bhanumathy M, M Pharma | Contact | 919986411152 | bhanumathy@olivelifesciences.com |
| Name | Affiliation | Role |
|---|---|---|
| Venkateshwarlu K, MD (Ayur) | Sreenivasa Clinic Diabetic Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sreenivasa Clinic Diabetic Research Center | Bangalore | Karnataka | 560050 | India |
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| Label | URL |
|---|---|
| Dietary supplements | View source |
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|
| BioTurmin-WD (Water dispersible curcuminoids) | Dietary Supplement |
|
| MaQxan (Tagetes erecta flower extract) | Dietary Supplement |
|
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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