None listed
Conditions
Interventions
Intervention1: Amla Extract: Amla Extract 500 mg capsule of M/s Arjuna Extract Limited,
500mg capsule twice daily to be taken orally for 3 months
Control Intervention1: Nil: Nil
Sponsors
Arjuna Natural Extracts Ltd
Eligibility
Inclusion 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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change in TC levels at the end of 90 days.Timepoint: Day 0 45 and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Mean change in CoQ10 levels at the end of 90 days. Mean change in HMGCoA reductase levels at the end of 90 days. Timepoint: Day 0 and 90 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Arjuna Natural Extracts Limited
Outcome results
None listed