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
Salacia bark extract
+ TLC
+ Sesame seed extract
Diabetes Mellitus+6
+ Endocrine System Diseases
+ Metabolic Diseases
Prevention Study
Summary
Study start date: April 1, 2012
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Srinivasa Clinic & Diabetic Care Center
Bangalore, IndiaOpen Srinivasa Clinic & Diabetic Care Center in Google Maps