Trial | NCT01680211  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Apr 30
2012
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Last Update
Sep 07
2012
Estimate

Dietary Supplement Salacia bark extract

Dietary Supplement Salacia leaf extract

Dietary Supplement Sesame seed extract

Behavioral TLC

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

Other Placebo

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

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 Experimental

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 Experimental

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

Placebo and TLC Placebo Comparator

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

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.
No Results Posted