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Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

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ClinicalTrials.gov Identifier: NCT03479983
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Arjuna Natural Limited

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE June 4, 2018
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
Change in Total Cholesterol [ Time Frame: Baseline, Day 45 & Day 90 ]
The change over time from the baseline to end of treatment, both within and between the group.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03479983 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2018)
  • Change in Triglycerides [ Time Frame: Baseline, Day 45 & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Low Density Lipoprotein Cholesterol [ Time Frame: Baseline, Day 45 & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in High Density Lipoprotein Cholesterol [ Time Frame: Baseline, Day 45 & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Very Low Density Lipoprotein Cholesterol [ Time Frame: Baseline, Day 45 & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Triglyceride /High Density Lipoprotein Cholesterol ratio [ Time Frame: Baseline, Day 45 & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Apolipoprotein A-1 [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Apolipoprotein B [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Apolipoprotein B/Apolipoprotein A-1 Ratio [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in hydroxymethylglutaryl-coenzyme A [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Coenzyme Q10 [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Atherogenic index of Plasma [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40) [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2018)
  • Change in Thyroid-stimulating hormone [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Homocysteine [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in High Sensitivity C-Reactive Protein [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
  • Change in Global Physical Activity Questionnaire [ Time Frame: Baseline & Day 90 ]
    The change over time from the baseline to end of treatment, both within and between the group.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
Official Title  ICMJE A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • Dietary Supplement: AMX160
    500 mg Phyllanthus emblica L. fresh fruit extract capsules
    Other Names:
    • Phyllanthus emblica L.
    • Indian Gooseberry
    • Emblica officinalis
  • Dietary Supplement: Placebo
    500 mg roasted rice powder in visually identical capsules
Study Arms  ICMJE
  • Experimental: AMX160
    500 mg (one capsule) x 2 times daily for 90 days
    Intervention: Dietary Supplement: AMX160
  • Placebo Comparator: Placebo
    500mg (one capsule) x 2 times daily for 90 days.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2018)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2019
Estimated Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Binu T Kuruvilla, Dr. 91-9447818432 drbinu@arjunanatural.com
Contact: Sooraj R 91-9847670997 sooraj@arjunanatural.com
Listed Location Countries  ICMJE Armenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03479983
Other Study ID Numbers  ICMJE AN-06ASE 0717H4-YSM01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
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.
Responsible Party Arjuna Natural Limited
Study Sponsor  ICMJE Arjuna Natural Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hamayak Sisakian, MD Yerevan State Medical University, Armenia
PRS Account Arjuna Natural Limited
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP