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.

Study Overview

• Status: Completed
• Conditions: Hyperlipidemia; Prediabetes
• Intervention / Treatment: Other: Placebo; Dietary supplement: Salacia bark extract; Behavioral: TLC; Dietary supplement: Sesame seed extract; Dietary supplement: Salacia leaf extract

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560050
      • Srinivasa Clinic & Diabetic Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)	Behavioral: TLC; Lifestyle changes include diet, exercise, weight loss, etc.; Dietary supplement: Sesame seed extract
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)	Behavioral: TLC; Lifestyle changes include diet, exercise, weight loss, etc.; Dietary supplement: Salacia leaf extract
Placebo Comparator: Placebo and TLC; Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)	Other: Placebo; Behavioral: TLC; Lifestyle changes include diet, exercise, weight loss, etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Sugar and lipid profiles	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).	baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical laboratory evaluations	Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis	0 and week 6

Collaborators and Investigators

• Sponsor: Olive Lifesciences Pvt Ltd
• Investigators: Principal Investigator: K R Raveendra, M.D, Srinivasa Clinic & Diabetic Care Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: September 3, 2012
• First Posted (Estimate): September 7, 2012

Study Record Updates

• Last Update Posted (Estimate): September 7, 2012
• Last Update Submitted That Met QC Criteria: September 3, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Blood Sugar,; Lipoproteins,; Salacia,; Sesame,; Prediabetes,; Hyperlipidemia,; Herbal supplement
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Lipid Metabolism Disorders; Dyslipidemias; Prediabetic State; Glucose Intolerance; Hyperlipidemias; Hyperlipoproteinemias
• Other Study ID Numbers: OL-S-OB-LP/03-12; CTRI/2012/05/002678 (Registry Identifier: Clinical Trials Registry - India (CTRI))