None listed
Conditions
Interventions
Intervention1: Amla Extract (AMX160): Amla Extract (AMX160) 500 mg capsule of M/s Arjuna Extract Limited, Kerala
Control Intervention1: Placebo: Placebo capsule of M/s Arjuna Extract Limited, Kerala
Sponsors
Arjuna Natural Extracts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged 30-65 years 2. Patients with dyslipidaemia having Triglycerides (TG) >200 mg/dL, LDL cholesterol > 130 mg/dL, Total cholesterol > 200 mg/dL and HDL cholesterol 3. Patients not taking any medication (including herbal product) for management of dyslipidaemia since last 4 weeks 4. Informed consent of the patient
Exclusion criteria
Exclusion criteria: 1. Patients with more than 2 of the following risk factors - 1.1. Cigarette smoking 1.2. Hypertension (BP > 140/90 mmHg or on antihypertensive medication) 1.3. Family history of premature CHD (CHD in male first degree relative 1.4. Age (men > 45 years; women > 55 years) 2. Patients 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. Patients with very high triglyceride levels i.e. > 500 mg/dL 4. Patients with FBS more than 150 mg/dL, using insulin, glitazones. Patients using other hypoglycaemics, dose of which is not stable in last one month 5. Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) 6. Patients with hepatic impairment (SGOT or SGPT levels > 3 Upper Limit of Normal (ULN)) or renal impairment (serum creatinine greater than or equal to 2.0 mg/dl) 7. Patients with any other severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures 8. Patients with known history of hypersensitivity to amla or any product containing amla extract 9. Patients with continuing history of alcohol and / or drug abuse. 10. Patients 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 |
|---|---|
| 1. Mean percent change in TG levels at the end of 12 weeks in the two groupsTimepoint: Day 0 and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean percent change in Total cholesterol, LDL and VLDL levels 2. Mean change in the Atherogenic Index of Plasma 3. Mean change in apolipoprotein B (apoB), apolipoprotein A1 (apoA1) and their ratio 4. Mean change in FPG and HbA1c levels 5. Mean change in hs-CRP, homocysteine, Coenzyme Q10 levels 6. Proportion of patients achieving ATP goals (Triglyceride 150 mg/dL, LDL 100 mg/dL, HDL 40) 7. Change in the HMG-CoA reductase activityTimepoint: Day 0 and Day 84 | — |
Countries
India
Contacts
Public ContactDr Deepa Subramanian
Arjuna Natural Extracts Limited
Outcome results
None listed