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Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Olive Lifesciences Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01680211
First received: August 29, 2012
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Prediabetes
Hyperlipidemia
 Dietary Supplement: Salacia bark extract
Dietary Supplement: Salacia leaf extract
Dietary Supplement: Sesame seed extract
Behavioral: TLC
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Olive Lifesciences Pvt Ltd:

Primary Outcome Measures:
  • Change in Blood Sugar and lipid profiles [ Time Frame: baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Clinical laboratory evaluations [ Time Frame: 0 and week 6 ] [ Designated as safety issue: Yes ]
    Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis


Enrollment: 40
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
 Dietary Supplement: Salacia bark extract Behavioral: TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Experimental: 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)
 Dietary Supplement: Sesame seed extract Behavioral: TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Experimental: 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)
 Dietary Supplement: Salacia leaf extract Behavioral: TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Placebo Comparator: Placebo and TLC
Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)
 Behavioral: TLC
Lifestyle changes include diet, exercise, weight loss, etc.
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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:

  1. Patients with severe liver, renal, cardiac or brain diseases.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01680211

Locations
India
Srinivasa Clinic & Diabetic Care Center
Bangalore, Karnataka, India, 560050
Sponsors and Collaborators
Olive Lifesciences Pvt Ltd
Investigators
Principal Investigator: K R Raveendra, M.D Srinivasa Clinic & Diabetic Care Center
  More Information

No publications provided

Responsible Party: Olive Lifesciences Pvt Ltd
ClinicalTrials.gov Identifier: NCT01680211     History of Changes
Other Study ID Numbers: OL-S-OB-LP/03-12, CTRI/2012/05/002678
Study First Received: August 29, 2012
Last Updated: September 3, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Olive Lifesciences Pvt Ltd:
Blood Sugar,
Lipoproteins,
Salacia,
Sesame,
 Prediabetes,
Hyperlipidemia,
Herbal supplement

Additional relevant MeSH terms:
Hyperlipidemias
Glucose Intolerance
Prediabetic State
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Hyperglycemia
Glucose Metabolism Disorders
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013