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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 and 60 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 60 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 | Capsule containing 250 mg of placebo, two times a day |
|
| BioTurmin | Experimental | Capsule containing 250 mg of BioTurmin (Curcuma longa rhizomes extract), two times a day |
|
| BioTurmin-WD | Experimental | Capsule containing 250 mg of BioTurmin-WD (water dispersible curcuminoids), two times a day |
|
| MaQxan | Experimental | Capsule containing 10 mg of MaQxan (Tagetes erecta flower extract), two times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement |
| ||
| BioTurmin (Curcuma longa rhizomes extract) |
| Measure | Description | Time Frame |
|---|---|---|
| change in urine cotinine and serum oxidative stress marker (malondialdehyde) level | Baseline, on day 30 and on day 60 |
| 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, on day 30 and on day 60 |
| 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, on day 30 and on day 60 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shivaprasad H N, 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 |
| Curcuma longa | View source |
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| Dietary Supplement |
|
| BioTurmin-WD (Water dispersible curcuminoids) | Dietary Supplement |
|
| MaQxan | Dietary Supplement |
|
| Tagetes erecta |
| View source |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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