Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia

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.

Study Overview

• Status: Unknown
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Dietary supplement: AMX160; Dietary supplement: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 132
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Binu T Kuruvilla, Dr.; Phone Number: 91-9447818432; Email: drbinu@arjunanatural.com
• Study Contact Backup: Name: Sooraj R; Phone Number: 91-9847670997; Email: sooraj@arjunanatural.com

Study Locations

• Armenia
  • Yerevan, Armenia, 375025
    • Recruiting
    • Clinic of General and Invasive Cardiology University Hospital 1, YSMU
    • Sub-Investigator: Laura Sahakyan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AMX160; 500 mg (one capsule) x 2 times daily for 90 days	Dietary supplement: AMX160; 500 mg Phyllanthus emblica L. fresh fruit extract capsules; Other Names: Phyllanthus emblica L.; Indian Gooseberry; Emblica officinalis
PLACEBO_COMPARATOR: Placebo; 500mg (one capsule) x 2 times daily for 90 days.	Dietary supplement: Placebo; 500 mg roasted rice powder in visually identical capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Cholesterol	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Triglycerides	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90
Change in Low Density Lipoprotein Cholesterol	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90
Change in High Density Lipoprotein Cholesterol	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90
Change in Very Low Density Lipoprotein Cholesterol	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90
Change in Triglyceride /High Density Lipoprotein Cholesterol ratio	The change over time from the baseline to end of treatment, both within and between the group.	Baseline, Day 45 & Day 90
Change in Apolipoprotein A-1	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Apolipoprotein B	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Apolipoprotein B/Apolipoprotein A-1 Ratio	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in hydroxymethylglutaryl-coenzyme A	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Coenzyme Q10	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Atherogenic index of Plasma	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40)	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Thyroid-stimulating hormone	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Homocysteine	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in High Sensitivity C-Reactive Protein	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Change in Global Physical Activity Questionnaire	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90

Collaborators and Investigators

• Sponsor: Arjuna Natural Limited
• Investigators: Principal Investigator: Hamayak Sisakian, MD, Yerevan State Medical University, Armenia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2018
• Primary Completion (ANTICIPATED): May 1, 2019
• Study Completion (ANTICIPATED): August 1, 2019

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: March 21, 2018
• First Posted (ACTUAL): March 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 10, 2019
• Last Update Submitted That Met QC Criteria: January 9, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Triglycerides; Total cholesterol; Indian gooseberry
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: AN-06ASE 0717H4-YSM01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data sharing can be carried out through a proper research proposal to the scientific review board of Arjuna Natural Ltd except in cases where Arjuna Natural Ltd. has no legal authority because the product has been out-licensed to another company or there is no feasible means to anonymise the data and redact personally identifiable information without compromising the privacy and confidentiality of research participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No