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

Prediabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01680211
• Other study ID #: OL-S-OB-LP/03-12
• Secondary ID: CTRI/2012/05/002
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: September 3, 2012
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: September 2012
• Source: Olive Lifesciences Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Hyperlipidemia
• Hyperlipidemias
• Prediabetes
• Prediabetic State

Intervention

Dietary Supplement:
• Salacia bark extract

• Salacia leaf extract

• Sesame seed extract

Behavioral:
• TLC
Lifestyle changes include diet, exercise, weight loss, etc.

Other:
• Placebo

Locations

Country	Name	City	State
India	Srinivasa Clinic & Diabetic Care Center	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Olive Lifesciences Pvt Ltd

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes