CTRI/2017/02/007829
Completed
未知
A prospective open label clinical study to evaluate the efficacy and safety of Amla extract in the subjects with Abnormal lipid levels
Arjuna Natural Extracts Ltd0 sites39 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arjuna Natural Extracts Ltd
- Enrollment
- 39
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subjects aged 18\-65 years.
- •2\.Inactive population (defined as less than 150 minutes of moderate\-intensity physical activity throughout the week, or less than 75 minutes of vigorous\-intensity physical activity throughout the week, or less than an equivalent combination of moderate\- and vigorous\-intensity activity).
- •3\.Subjects with abnormal lipid levels having Triglycerides \>200 mg/dL, LDL cholesterol \> 130 mg/dL and Total cholesterol \> 200 mg/dL.
- •4\.Subjects not taking any medication (including herbal product) for management of abnormal lipid levels since last 4 weeks .
- •5\.Informed consent of the patient.
Exclusion Criteria
- •1\.Subjects with more than 2 of the following risk factors \-
- •Cigarette smoking
- •Hypertension (BP \>140/90 mmHg or on antihypertensive medication)
- •Family history of premature CHD (CHD in male first degree relative \<55 years; CHD in female first degree relative \<65 years)
- •Age (men \>45 years; women \>55 years).
- •2\.Subjects with uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history of stroke, myocardial infarction, life\-threatening arrhythmia, or coronary revascularization within the preceding 6 months; unstable angina; congestive heart failure; known or suspected clinically significant valvular heart disease or uncontrolled hypertension ( \>160/100 mm of Hg or use of antihypertensive medications, dose of which is not stable in the last one month).
- •3\.Subjects with very high triglyceride levels i.e. \> 500 mg/dL.
- •4\.Subjects with diabetes (FBS \>150 mg/dL),, using insulin, glitazones. Subjects using other hypoglycaemics, dose of which is not stable in last one month.
- •5\.Pregnancy, lactation and female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilisation).
- •6\.Subjects with hepatic impairment (SGOT or SGPT levels \> 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine \>\= 2\.0 mg/dl).
Outcomes
Primary Outcomes
Not specified
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