A prospective open label clinical study to evaluate the efficacy and safety of Amla extract in the subjects with Abnormal lipid levels
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Mean percent change in TC levels at the end of 90 days.
Study Overview
Brief Summary
This clinical study is being planned to assess the efficacy and safety of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala for management of abnormal lipid levels in male and female subjects aged 18 to 65. Beside the conventional lipid parameters like TG, TC, LDL, and HDL various other parameters have shown correlation with progression of coronary artery disease. The most important of these parameters include the Atherogenic Index of Plasma (AIP), Apo lipoproteins A1, Apo lipoprotein B and their ratio, Coenzyme Q10 and chronic inflammatory markers like hs-CRP.12-16 This study is being planned to assess the effect of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala on these parameters besides the effect on the conventional lipid parameters.
The objective of this clinical study is to evaluate the efficacy and safety of Amla Extract of M/s Arjuna Natural Extracts Limited, Kerala in subjects with abnormal lipid levels aged 18-65 years.
Type of Study: Prospective, open label, single centre study on subjects with abnormal lipid levels to access the safety and efficacy of the study medication.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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). 7.Subjects with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures. 8.Subjects with known history of hypersensitivity to amla or any product containing amla extract . 9.Subjects with continuing history of alcohol and / or drug abuse. 10.Subjects with any other serious concurrent illness or malignancy. 11.Participation in another clinical trial in the past 3 months.
Outcomes
Primary Outcomes
Mean percent change in TC levels at the end of 90 days.
Time Frame: Day 0 45 and 90
Secondary Outcomes
- Mean change in apolipoprotein B (apoB), apolipoprotein A1 (apoA1),triglycerides,LDL, VLDL, atherogenic index of plasma (AIP), at the end of 90 days.(Proportion of subjects achieving ATP goals (Triglyceride less than 150 mg/dL, LDL less than 100 mg/dL, HDL more than 40) at the end of the study.)