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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01680211

Enrollment

Registered

2012-09-07

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2012-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, Prediabetes

Keywords

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

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.

Interventions

DIETARY_SUPPLEMENTSalacia bark extract

DIETARY_SUPPLEMENTSalacia leaf extract

DIETARY_SUPPLEMENTSesame seed extract

BEHAVIORALTLC

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

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026