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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2012/05/002678 | Registry Identifier | Clinical Trials Registry - India (CTRI) |
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Objective of this study is to determine the safety and efficacy of administration of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) for 6 weeks in the management of prediabetes and mild to moderate hyperlipidemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salacia bark extract (SR-B-01) and TLC | Experimental | Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
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| Sesame seeds extract (SI-S-01) and TLC | Experimental | Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
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| Salacia leaf extract (SR-L-01) and TLC | Experimental | Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC) |
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| Placebo and TLC | Placebo Comparator | Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salacia bark extract | Dietary Supplement |
| ||
| Salacia leaf extract |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Blood Sugar and lipid profiles | Change in of blood sugar out come will be measured by Fasting Blood Sugar (FBS), Oral Glucose Tolerance Test (OGTT) and Postprandial Blood Sugar (PPBS). Change in lipid profiles are measured by Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC). | baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratory evaluations | Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis | 0 and week 6 |
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Inclusion Criteria:
As per ATP III guidelines: Baseline LDL ranging 160-189 mg/dL, TC >200 mg/dL and with no or one of the below risk factors
Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
Being mentally competent and able to understand all study requirements and sign the informed consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| K R Raveendra, M.D | Srinivasa Clinic & Diabetic Care Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinivasa Clinic & Diabetic Care Center | Bangalore | Karnataka | 560050 | India |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| D006949 | Hyperlipidemias |
| C557674 | SeSAME syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Dietary Supplement |
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| Sesame seed extract | Dietary Supplement |
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| TLC | Behavioral | Lifestyle changes include diet, exercise, weight loss, etc. |
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| Placebo | Other |
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| D004700 | Endocrine System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |