Clinical trial NCT03479983: Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
Official title: A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Indian gooseberry
Total cholesterol
Triglycerides
Lead sponsor: Arjuna Natural Limited
Sponsor class: INDUSTRY
First posted: 2018-03-27
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel assignment
Primary purpose: TREATMENT

Brief summary: This study evaluates the efficacy of a fresh fruit extract of Indian Gooseberry (AMX160) for the attenuation of increased blood cholesterol, LDL cholesterol and triglycerides in patients with hypercholesterolemia.

Detailed description: Phyllanthus emblica L. fruit (Emblica officinalis) has potent antioxidant properties. Animal studies indicate that flavanoids from E. officinalis effectively reduced lipid levels in serum and tissues and had a significant inhibitory effect on hepatic hydroxymethylglutaryl-coenzyme A reductase activity.

The primary aim of this study is to determine whether Phyllanthus emblica L. fruit extract AMX160 is an effective treatment for hypercholesterolemia patients as compared to placebo. The investigators hypothesize that Phyllanthus emblica L. fruit extract AMX160 will significantly lower the total cholesterol as compared to placebo in patients with Hypercholesterolemia. A total of 132 patients including males and females with hypercholesterolemia will be assigned at random to one of the two investigational products. The study is expected to have a treatment duration of 90 ± 10 days and a total duration of 118 days including 14 days of grace period and 14 days of screening period per patient.

Eligibility 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).

Primary outcomes:
measure: Change in Total Cholesterol
timeFrame: Baseline, Day 45 & Day 90
Secondary outcomes:
measure: Change in Triglycerides
timeFrame: Baseline, Day 45 & Day 90
measure: Change in Low Density Lipoprotein Cholesterol
timeFrame: Baseline, Day 45 & Day 90
measure: Change in High Density Lipoprotein Cholesterol
timeFrame: Baseline, Day 45 & Day 90
measure: Change in Very Low Density Lipoprotein Cholesterol
timeFrame: Baseline, Day 45 & Day 90
measure: Change in Triglyceride /High Density Lipoprotein Cholesterol ratio
timeFrame: Baseline, Day 45 & Day 90
measure: Change in Apolipoprotein A-1
timeFrame: Baseline & Day 90
measure: Change in Apolipoprotein B
timeFrame: Baseline & Day 90
measure: Change in Apolipoprotein B/Apolipoprotein A-1 Ratio
timeFrame: Baseline & Day 90
measure: Change in hydroxymethylglutaryl-coenzyme A
timeFrame: Baseline & Day 90
measure: Change in Coenzyme Q10
timeFrame: Baseline & Day 90
measure: Change in Atherogenic index of Plasma
timeFrame: Baseline & Day 90
measure: Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40)
timeFrame: Baseline & Day 90
Other outcomes:
measure: Change in Thyroid-stimulating hormone
timeFrame: Baseline & Day 90
measure: Change in Homocysteine
timeFrame: Baseline & Day 90
measure: Change in High Sensitivity C-Reactive Protein
timeFrame: Baseline & Day 90
measure: Change in Global Physical Activity Questionnaire
timeFrame: Baseline & Day 90
Locations:
city: Yerevan
country: Armenia
facility: Clinic of General and Invasive Cardiology University Hospital 1, YSMU
Study officials:
affiliation: Yerevan State Medical University, Armenia
name: Hamayak Sisakian, MD
role: PRINCIPAL_INVESTIGATOR
References: