Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

NCT03479983 | Unknown

• 1 other identifier: AN-06ASE 0717H4-YSM01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Keywords

Indian gooseberry; Total cholesterol; Triglycerides

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in Triglycerides

  Baseline, Day 45 & Day 90

• Change in Low Density Lipoprotein Cholesterol

  Baseline, Day 45 & Day 90

• Change in High Density Lipoprotein Cholesterol

  Baseline, Day 45 & Day 90

• Change in Very Low Density Lipoprotein Cholesterol

  Baseline, Day 45 & Day 90

• Change in Triglyceride /High Density Lipoprotein Cholesterol ratio

  Baseline, Day 45 & Day 90

Other Outcomes (4)

• Change in Thyroid-stimulating hormone

  Baseline & Day 90

• Change in Homocysteine

  Baseline & Day 90

• Change in High Sensitivity C-Reactive Protein

  Baseline & Day 90

Study Arms (2)

AMX160

EXPERIMENTAL

500 mg (one capsule) x 2 times daily for 90 days

Dietary Supplement: AMX160

Placebo

PLACEBO COMPARATOR

500mg (one capsule) x 2 times daily for 90 days.

Dietary Supplement: Placebo

Interventions

AMX160 DIETARY_SUPPLEMENT

500 mg Phyllanthus emblica L. fresh fruit extract capsules

Also known as: Phyllanthus emblica L., Indian Gooseberry, Emblica officinalis

AMX160

Placebo DIETARY_SUPPLEMENT

500 mg roasted rice powder in visually identical capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Very high triglyceride levels i.e. \> 500 mg/dL
• Diabetes (Fasting Blood Sugar\>150 mg/dL), using insulin, glitazones , another hypoglycemic dose of which is not stable in last one month
• Pregnancy, lactation and female patients not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization)
• 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)
• Severe systemic illness and in the opinion of the investigator would be noncompliant with the visit schedule or study procedures
• Known history of hypersensitivity to Indian Gooseberry or any product containing Indian Gooseberry extract
• Patients with history of alcohol intake (For females \>3 drinks / day or \>7 drinks / week. For Males \>4 drinks/ day or \> 14 drinks / week).
• Patients taking any narcotics and prohibited substances.
• Serious concurrent illness or malignancy.
• Agreements of participation in another clinical trial in the past 3 months
• Two of the following risk factors:
• Cigarette smoking (Current / Previous smoker \< 1 yr)
• Hypertension (BP \>140/90 mmHg or on antihypertensive medication)
• Low HDL cholesterol (\<40 mg/dL)

Sponsors & Collaborators

• Arjuna Natural Limited: lead

Study Sites (1)

Clinic of General and Invasive Cardiology University Hospital 1, YSMU

Yerevan, 375025, Armenia

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hamayak Sisakian, MD

  Yerevan State Medical University, Armenia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Binu T Kuruvilla, Dr.

CONTACT

91-9447818432; drbinu@arjunanatural.com

Sooraj R

CONTACT

91-9847670997; sooraj@arjunanatural.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: June 4, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

AR (1)