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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:
ClinicalTrials.gov Identifier:
NCT01680211
First Posted: September 7, 2012
Last Update Posted: September 7, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Olive Lifesciences Pvt Ltd
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Registry Identifier: Clinical Trials Registry - India (CTRI) )
First Submitted: August 29, 2012
First Posted: September 7, 2012
Last Update Posted: September 7, 2012
Last Verified: September 2012

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

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