Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

Inclusion Criteria:

• 1. Males and females aged 18 to 65 years with hypercholesterolemia symptoms: bloodTriglycerides, >200 mg/dL, blood cholesterol >200 mg/dL, blood LDL cholesterol >130mg/dL Other requirements for inclusion in the study are:

2. Moderate-intensity physical activity (less than 150 minutes or less than 75 minutes ofvigorous-intensity physical activity throughout the week) 3. No medication taken formanagement of hypercholesterolemia during last 4 weeks.

3. Ability to understand and provide signed informed consent. 5. Ability to participate inthe study.

Exclusion Criteria:

1. Uncontrolled cardiovascular disease or advanced atherosclerosis (e.g. history ofstroke, myocardial infarction, life- threatening arrhythmia, or coronaryrevascularization within the preceding 6 months; unstable angina; congestive heartfailure; known or suspected clinically significant valvular heart disease oruncontrolled hypertension (>160/100 mm of Hg or use of antihypertensive medications,dose of which is not stable in the last one month)

2. Very high triglyceride levels i.e. > 500 mg/dL

3. Diabetes (Fasting Blood Sugar>150 mg/dL), using insulin, glitazones , anotherhypoglycemic dose of which is not stable in last one month

4. Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgicalsterilization)

5. Hepatic impairment (Alanine transaminase or Aspartate transaminase levels > 3.0 mg/dlUpper Limit of Normal (ULN)) or renal impairment (serum creatinine≥ 2.0 mg/dl)

6. Severe systemic illness and in the opinion of the investigator would be noncompliantwith the visit schedule or study procedures

7. Known history of hypersensitivity to Indian Gooseberry or any product containingIndian Gooseberry extract

8. Patients with history of alcohol intake (For females >3 drinks / day or >7 drinks /week. For Males >4 drinks/ day or > 14 drinks / week).

9. Patients taking any narcotics and prohibited substances.

10. Serious concurrent illness or malignancy.

11. Agreements of participation in another clinical trial in the past 3 months

12. Two of the following risk factors:

13. Cigarette smoking (Current / Previous smoker < 1 yr)

14. Hypertension (BP >140/90 mmHg or on antihypertensive medication)

15. Low HDL cholesterol (<40 mg/dL)

16. Family history of premature CHD (CHD in male first degree relative <55 years; CHDin female first degree relative <65 years).