Safety and efficacy of herbal supplements in prediabetic and mild to moderate hyperlipidemic subjects.
- Conditions
- Health Condition 1: null- Prediabetes and mild to moderate hyperlipidemia
- Registration Number
- CTRI/2012/05/002678
- Lead Sponsor
- Olive Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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 glucose tolerance (2-hour post 75 g OGTT glucose levels in the range of >=140 to <= 200 mg/dL)
3.Impaired fasting sugar (FBS 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
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 that would affect evaluation 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 Change in FBS,OGTT, and PPBS levels <br/ ><br>Change in LDL, VLDL, HDL and TC levelsTimepoint: 3 and 6 weeks <br/ ><br>3 and 6 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerabilityTimepoint: 6 weeks