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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

August 29, 2012
September 3, 2012
April 2012
June 2012   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01680211 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Herbal Supplements in Prediabetic and Mild to Moderate Hyperlipidemic Patients
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Prediabetes
  • Hyperlipidemia
  • Dietary Supplement: Salacia bark extract
  • Dietary Supplement: Salacia leaf extract
  • Dietary Supplement: Sesame seed extract
  • Behavioral: TLC
    Lifestyle changes include diet, exercise, weight loss, etc.
  • Other: Placebo
  • 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)
    Interventions:
    • Dietary Supplement: Salacia bark extract
    • Behavioral: TLC
  • 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)
    Interventions:
    • Dietary Supplement: Sesame seed extract
    • Behavioral: TLC
  • 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)
    Interventions:
    • Dietary Supplement: Salacia leaf extract
    • Behavioral: TLC
  • Placebo Comparator: Placebo and TLC
    Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)
    Interventions:
    • Behavioral: TLC
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01680211
OL-S-OB-LP/03-12, CTRI/2012/05/002678
Yes
Olive Lifesciences Pvt Ltd
Olive Lifesciences Pvt Ltd
Not Provided
Principal Investigator: K R Raveendra, M.D Srinivasa Clinic & Diabetic Care Center
Olive Lifesciences Pvt Ltd
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP