Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety Study of Herbal Supplements (SR-L-01, SR-B-01 and SI-S-01) in the Management of Prediabetes and Mild to Moderate Hyperlipidemia

Conditions
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Prediabetes, Hyperlipidemia

Intervention / Treatment
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* Dietary Supplement: Salacia bark extract
* Dietary Supplement: Salacia leaf extract
* Dietary Supplement: Sesame seed extract
* Behavioral: TLC
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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 Current cigarette smoking Family history of premature Coronary Heart Disease(CHD); in male first degree relative <55 years; in female first degree relative <65 years) Hypertension (BP >140/90 mmHg or on antihypertensive medication) Low HDL-C (<40 mg/dL) Age (men > 40 years) 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: Patients with severe liver, renal, cardiac or brain diseases. Pregnant or lactating women or women of child bearing potential whom are not practicing a reliable form of birth control (either with IUD or with stable usage of oral contraceptives). Unable to complete follow up. Subjects on any medication that would affect evaluation like Statins.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Salacia bark extract (SR-B-01) and TLC<br>Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC) | Dietary Supplement: Salacia bark extract<br> <br> Behavioral: TLC<br>* Lifestyle changes include diet, exercise, weight loss, etc.<br>|
| Experimental: Sesame seeds extract (SI-S-01) and TLC<br>Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC) | Dietary Supplement: Sesame seed extract<br> <br> Behavioral: TLC<br>* Lifestyle changes include diet, exercise, weight loss, etc.<br>|
| Experimental: Salacia leaf extract (SR-L-01) and TLC<br>Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC) | Dietary Supplement: Salacia leaf extract<br> <br> Behavioral: TLC<br>* Lifestyle changes include diet, exercise, weight loss, etc.<br>|
| Placebo Comparator: Placebo and TLC<br>Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC) | Behavioral: TLC<br>* Lifestyle changes include diet, exercise, weight loss, etc.<br>Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blood Sugar,, Lipoproteins,, Salacia,, Sesame,, Prediabetes,, Hyperlipidemia,, Herbal supplement