A study of Herbal product on Hyperlipidemia and Prediabetes patients
- Conditions
- Health Condition 1: null- subjects with newly diagnosed mild to moderate hyperlipidemia and prediabetes
- Registration Number
- CTRI/2013/07/003812
- Lead Sponsor
- T Stanes Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 20
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 CHD (CHD in male first degree relative <55 years; CHD 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; women > 40 years)
2) Impaired fasting sugar (FBS levels in the range of >= 100 to <=125 mg/dL)
3) Being mentally competent and able to understand all study requirements and sign the informed consent form.
1) Patients with severe liver, renal, cardiac or brain diseases.
2) Pregnant or lactating women or women of childbearing 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 like Statins.
5) Allergic to any medication.
6) With a history of alcohol and/or drug abuse.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To examine the effect of the test substance on Fasting Blood Sugar (FBS) and Postprandial blood sugar (PPBS)& Low Density Lipoprotein (LDL), Very Low Density Lipoprotein (VLDL), High Density Lipoprotein (HDL) and Total Cholesterol (TC)Timepoint: Assessment of efficacy will be done on Day 0, 20, 40 and 60
- Secondary Outcome Measures
Name Time Method Safety and tolerability [Physical examination and Clinical laboratory evaluations will be performed during initial and final visits (day 0 and day 60): ECG, haematology (CBP), biochemical tests (blood urea, and serum creatinine), liver function tests and urine analysis].Timepoint: Assessment of efficacy and safety will be done on Day 0 and 60.