TCTR20140523002
Completed
Phase 2
Comparative Study of Efficacy and Adverse Effects of Triphala versus Simvastatin in Blood Lipids Reduction in Dyslipidemia Patients. (Clinical Trial Phase II)
Department for Development of Thai Trditional and Alternative Medicine0 sites60 target enrollmentMay 23, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dyslipidemia
- Sponsor
- Department for Development of Thai Trditional and Alternative Medicine
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1 Body Mass Index 18 to 35 kilometer per square meter
- •2 Total Cholesterol 200 to 300 milligram per deciliter and Low Density Lipoprotein cholesterol 130 to 189 milligram per deciliter
- •3 have at least 2 risk factors listed below
- •Cigarette smoking
- •Hypertension Blood pressure more than 140 over 90 milimeter of mercury or on antihypertensive medication
- •Low High Density Lipoprotein cholesterol
- •Family history of premature chronic heart disease CHD in male first degree relative
- •Age men more than 45 years women more than 55 years
- •4 Volunteer have a normal Complete Blood Count laboratory and liver function tests
- •5 volunteer are currently use medicine for lipid reduction They must stop the drug for a period of 30 days before the start of medication project in order to get rid of fat levels of drugs from body and blood
Exclusion Criteria
- •1 Dyslipidemia with secondary type is caused by one or more of the following diseases nephrotic syndrome cholestasis hypothyroidism
- •2 who eat other herbal medicines or supplements that affect blood fat levels such as steroid tegretol cyclosporine fish oil cholesterol absorption inhibitor fibrate Niacin acid binding Bile resins Statins probucol thiazides beta blockers testosterone estrogen progestogens glucocorticoids etc that can t stop the drug
- •3 Who is participating in other research projects
- •4 History of allergy or Simvastatin or allergy herbal medicine
- •5 had high risk factors for heart diseases and blood diseases such as cardiovascular leaders and those who have other diseases that have a risk of coronary artery disease are equivalent type II diabetes ischemic stroke which is caused by atherosclerosis carotid artery carotid artery transient ischemic attack Symptomatic disease peripheral arterial disease abdominal aortic aneurysm and those with vascular complications
- •6 Liver cancer or complications of liver and kidney dysfunction is Glomerular filtration rate less than 60 mililiter per min
- •7 Pregnant or nursing child
Outcomes
Primary Outcomes
Not specified
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