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OpenTrials
Completed

NCT Number: NCT01680211

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Srinivasa Clinic & Diabetic Care Center

Bangalore, Karnataka, 560050, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salacia bark extract

Dietary Supplement

Salacia leaf extract

Dietary Supplement

Sesame seed extract

Dietary Supplement

TLC

Behavioral

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

Placebo

Other

Primary outcomes

  1. Change in Blood Sugar and lipid profiles

    Time frame: 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 outcomes

  1. Clinical laboratory evaluations

    Time frame: 0 and week 6

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

Sponsors and collaborators

Lead sponsor

Olive Lifesciences Pvt Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 7, 2012
Registry last updated
Sep 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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