Completed

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

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What is being tested

Salacia bark extract

+ TLC

+ Sesame seed extract

Dietary SupplementBehavioralOther
Who is being recruted

Diabetes Mellitus+6

+ Endocrine System Diseases

+ Metabolic Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: April 2012
See protocol details

Summary

Principal SponsorOlive Lifesciences Pvt Ltd
Last updated: September 7, 2012
Sourced from a government-validated database.Claim as a partner

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.

NCT01680211
Principal SponsorOlive Lifesciences Pvt Ltd
Last updated: September 7, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Diabetes MellitusEndocrine System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersDyslipidemiasLipid Metabolism DisordersHyperlipidemiasPrediabetic State

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.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Group II

Experimental
Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Group III

Experimental
Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Group IV

Placebo
Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)

Study 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 &amp; Diabetic Care Center

Bangalore, IndiaOpen Srinivasa Clinic &amp; Diabetic Care Center in Google Maps
CompletedOne Study Center