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

Not Applicable

Completed

• Conditions: Prediabetes; Hyperlipidemia
• Interventions: Dietary Supplement: Salacia bark extract; Dietary Supplement: Sesame seed extract; Dietary Supplement: Salacia leaf extract; Behavioral: TLC; Other: Placebo

• Registration Number: NCT01680211
• Lead Sponsor: Olive Lifesciences Pvt Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-08-29
• Status Verified: 2012-09
• Study First Submitted QC: 2012-09-03
• Last Update Submitted: 2012-09-03
• Study First Posted: 2012-09-07
• Last Update Posted: 2012-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Salacia bark extract (SR-B-01) and TLC	Salacia bark extract	Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Salacia bark extract (SR-B-01) and TLC	TLC	Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Sesame seeds extract (SI-S-01) and TLC	Sesame seed extract	Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Sesame seeds extract (SI-S-01) and TLC	TLC	Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Salacia leaf extract (SR-L-01) and TLC	Salacia leaf extract	Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Salacia leaf extract (SR-L-01) and TLC	TLC	Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)
Placebo and TLC	TLC	Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)
Placebo and TLC	Placebo	Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)

Primary Outcome Measures

Name	Time	Method
Change in Blood Sugar and lipid profiles	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

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

Trial Locations

Locations (1)

Srinivasa Clinic & Diabetic Care Center; 🇮🇳 Bangalore, Karnataka, India