Safety and efficacy of herbal supplements in prediabetic and mild to moderate hyperlipidemic subjects.

Completed

• Conditions: Prediabetes and mild to moderate hyperlipidemia

• Registration Number: CTRI/2012/05/002678
• Lead Sponsor: Olive Lifesciences Pvt Ltd

Brief Summary

This study is a randomized, double blind, parallel group, placebo controlled trial determining the safety and efficacy of herbal supplements (Salacia leaf extract, Salacia root extract and Sesame seed extract) in the management of prediabetes and mild to moderate hyperlipidemia. The primary outcome measures will be reduction in FBS, OGTT, PPBS, LDL, VLDL, HDL and TC at 6 weeks. The secondary outcomes will be Safety and tolerability at 6 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-04
• Last Update Posted: 2012-08-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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 CHD (CHD in male first degree relative <55 years; CHD 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; women ≥ 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 (FBS 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 childbearing 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 5.Allergic to any medication 6.With a history of alcohol and/or drug abuse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in FBS,OGTT, and PPBS levels	3 and 6 weeks | 3 and 6 weeks
Change in LDL, VLDL, HDL and TC levels	3 and 6 weeks | 3 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	6 weeks

Trial Locations

Locations (1)

Srinivasa Clinic & Diabetic Care Center; 🇮🇳 Bangalore, KARNATAKA, India

Srinivasa Clinic & Diabetic Care Center

🇮🇳Bangalore, KARNATAKA, India

Dr K R Raveendra

Principal investigator

9448134587

drkrraveendra@gmail.com