NCT01680211CompletedNot Applicable
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
Olive Lifesciences Pvt Ltd2 sites in 1 country40 target enrollmentStarted: April 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change in Blood Sugar and lipid profiles
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Change in Blood Sugar and lipid profiles
Time Frame: baseline and 6 weeks
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).
Secondary Outcomes
- Clinical laboratory evaluations(0 and week 6)
Investigators
Study Sites (2)
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