Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients
NCT ID: NCT01680211
Last Updated: 2012-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2012-04-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Salacia bark extract (SR-B-01) and TLC
Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Salacia bark extract
TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Sesame seeds extract (SI-S-01) and TLC
Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Sesame seed extract
TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Salacia leaf extract (SR-L-01) and TLC
Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Salacia leaf extract
TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Placebo and TLC
Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)
TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Placebo
Interventions
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Salacia bark extract
Salacia leaf extract
Sesame seed extract
TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
65 Years
ALL
No
Sponsors
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Olive Lifesciences Pvt Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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K R Raveendra, M.D
Role: PRINCIPAL_INVESTIGATOR
Srinivasa Clinic & Diabetic Care Center
Locations
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Srinivasa Clinic & Diabetic Care Center
Bangalore, Karnataka, India
Countries
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Other Identifiers
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CTRI/2012/05/002678
Identifier Type: REGISTRY
Identifier Source: secondary_id
OL-S-OB-LP/03-12
Identifier Type: -
Identifier Source: org_study_id