Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03479983
• Date of registration: 21/03/2018
• Prospective Registration: Yes
• Primary sponsor: Arjuna Natural Limited
• Public title: Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
• Scientific title: A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
• Date of first enrolment: June 4, 2018
• Target sample size: 132
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03479983
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

Armenia

Contacts

• Name: Hamayak Sisakian, MD
• Affiliation: Yerevan State Medical University, Armenia

• Name: Binu T Kuruvilla, Dr.

Key inclusion & exclusion criteria

Inclusion Criteria:

- 1. Males and females aged 18 to 65 years with hypercholesterolemia symptoms: blood
Triglycerides, >200 mg/dL, blood cholesterol >200 mg/dL, blood LDL cholesterol >130
mg/dL

Other requirements for inclusion in the study are:

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

4. Ability to understand and provide signed informed consent. 5. Ability to participate in
the study.

Exclusion Criteria:

1. 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)

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

3. Diabetes (Fasting Blood Sugar>150 mg/dL), using insulin, glitazones , another
hypoglycemic 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 surgical
sterilization)

5. Hepatic impairment (Alanine transaminase or Aspartate transaminase levels > 3.0 mg/dl
Upper 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 noncompliant
with the visit schedule or study procedures

7. Known history of hypersensitivity to Indian Gooseberry or any product containing
Indian 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:

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

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

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

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Dietary Supplement: Placebo

Dietary Supplement: AMX160

Primary Outcome(s)

Change in Total Cholesterol [Time Frame: Baseline, Day 45 & Day 90]

Secondary Outcome(s)

Change in Atherogenic index of Plasma [Time Frame: Baseline & Day 90]

Change in Low Density Lipoprotein Cholesterol [Time Frame: Baseline, Day 45 & Day 90]

Change in Apolipoprotein A-1 [Time Frame: Baseline & Day 90]

Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40) [Time Frame: Baseline & Day 90]

Change in Coenzyme Q10 [Time Frame: Baseline & Day 90]

Change in Very Low Density Lipoprotein Cholesterol [Time Frame: Baseline, Day 45 & Day 90]

Change in Apolipoprotein B/Apolipoprotein A-1 Ratio [Time Frame: Baseline & Day 90]

Change in High Density Lipoprotein Cholesterol [Time Frame: Baseline, Day 45 & Day 90]

Change in Triglyceride /High Density Lipoprotein Cholesterol ratio [Time Frame: Baseline, Day 45 & Day 90]

Change in Apolipoprotein B [Time Frame: Baseline & Day 90]

Change in hydroxymethylglutaryl-coenzyme A [Time Frame: Baseline & Day 90]

Change in Triglycerides [Time Frame: Baseline, Day 45 & Day 90]

Secondary ID(s)

AN-06ASE 0717H4-YSM01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors