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

Primary Purpose

Prediabetes, Hyperlipidemia

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Salacia bark extract

Salacia leaf extract

Sesame seed extract

TLC

Placebo

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring Blood Sugar,, Lipoproteins,, Salacia,, Sesame,, Prediabetes,, Hyperlipidemia,, Herbal supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL)
Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL)
Being mentally competent and able to understand all study requirements and sign the informed consent form.

Exclusion Criteria:

Patients with severe liver, renal, cardiac or brain diseases.
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).
Unable to complete follow up.
Subjects on any medication that would affect evaluation like Statins.

Sites / Locations

Srinivasa Clinic & Diabetic Care Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Salacia bark extract (SR-B-01) and TLC

Sesame seeds extract (SI-S-01) and TLC

Salacia leaf extract (SR-L-01) and TLC

Placebo and TLC

Arm Description

Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Clinical laboratory evaluations

Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis

Full Information

NCT ID

NCT01680211

First Posted

August 29, 2012

Last Updated

September 3, 2012

Sponsor

Olive Lifesciences Pvt Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01680211

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Olive Lifesciences Pvt Ltd

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes, Hyperlipidemia

Keywords

Blood Sugar,, Lipoproteins,, Salacia,, Sesame,, Prediabetes,, Hyperlipidemia,, Herbal supplement

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Salacia bark extract (SR-B-01) and TLC

Arm Type

Experimental

Arm Description

Capsules containing 250mg of salacia bark extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Arm Title

Sesame seeds extract (SI-S-01) and TLC

Arm Type

Experimental

Arm Description

Capsules containing 250mg of sesame seed extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Arm Title

Salacia leaf extract (SR-L-01) and TLC

Arm Type

Experimental

Arm Description

Capsules containing 250mg of salacia leaf extract,two times a day along with Therapeutic Lifestyle Change (TLC)

Arm Title

Placebo and TLC

Arm Type

Placebo Comparator

Arm Description

Capsules containing 250mg of placebo,two times a day along with Therapeutic Lifestyle Change (TLC)

Intervention Type

Dietary Supplement

Intervention Name(s)

Salacia bark extract

Intervention Type

Dietary Supplement

Intervention Name(s)

Salacia leaf extract

Intervention Type

Dietary Supplement

Intervention Name(s)

Sesame seed extract

Intervention Type

Behavioral

Intervention Name(s)

TLC

Intervention Description

Lifestyle changes include diet, exercise, weight loss, etc.

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change in Blood Sugar and lipid profiles

Description

Time Frame

baseline and 6 weeks

Secondary Outcome Measure Information:

Title

Clinical laboratory evaluations

Description

Electrocardiography (ECG), haematology (Complete Blood Count), biochemical tests (blood urea, and serum creatinine), liver function tests and urine routine analysis

Time Frame

0 and week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Impaired glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of ≥140 to ≤ 200 mg/dL) Impaired fasting sugar (Fasting blood sugar levels in the range of ≥ 100 to ≤125 mg/dL) Being mentally competent and able to understand all study requirements and sign the informed consent form. Exclusion Criteria: Patients with severe liver, renal, cardiac or brain diseases. 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). Unable to complete follow up. Subjects on any medication that would affect evaluation like Statins.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

K R Raveendra, M.D

Organizational Affiliation

Srinivasa Clinic & Diabetic Care Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Srinivasa Clinic & Diabetic Care Center

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560050

Country

India

12. IPD Sharing Statement

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

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