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

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

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.

Inclusion Criteria:

1. 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)

2. Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)

3. Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)

4. Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

1. Patients with severe liver, renal, cardiac or brain diseases.
2. 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).
3. Unable to complete follow up.
4. Subjects on any medication that would affect evaluation like Statins.