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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

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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Dietary Supplement: AMX160 Dietary Supplement: Placebo Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study of Phyllanthus Emblica L. Fruit Extract (AMX160) in Patients With Hypercholesterolemia
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479983


Contacts
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Contact: Binu T Kuruvilla, Dr. 91-9447818432 drbinu@arjunanatural.com
Contact: Sooraj R 91-9847670997 sooraj@arjunanatural.com

Locations
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Armenia
Clinic of General and Invasive Cardiology University Hospital 1, YSMU Recruiting
Yerevan, Armenia, 375025
Sub-Investigator: Laura Sahakyan, MD         
Sponsors and Collaborators
Arjuna Natural Limited
Investigators
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Principal Investigator: Hamayak Sisakian, MD Yerevan State Medical University, Armenia

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Responsible Party: Arjuna Natural Limited
ClinicalTrials.gov Identifier: NCT03479983     History of Changes
Other Study ID Numbers: AN-06ASE 0717H4-YSM01
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arjuna Natural Limited:
Indian gooseberry
Total cholesterol
Triglycerides

Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases