Back to resultsEffect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
Primary Purpose
Hypercholesterolemia
Status
Unknown status
Phase
Not Applicable
Locations
Armenia
Study Type
Interventional
Intervention
AMX160
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring Indian gooseberry, Total cholesterol, Triglycerides
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:
- 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)
- Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
Sites / Locations
- Clinic of General and Invasive Cardiology University Hospital 1, YSMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AMX160
Placebo
Arm Description
500 mg (one capsule) x 2 times daily for 90 days
500mg (one capsule) x 2 times daily for 90 days.
Outcomes
Primary Outcome Measures
Change in Total Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Secondary Outcome Measures
Change in Triglycerides
The change over time from the baseline to end of treatment, both within and between the group.
Change in Low Density Lipoprotein Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Change in High Density Lipoprotein Cholesterol
The change over time from the baseline to end of treatment, both within and between the group.
Change in Very Low Density Lipoprotein Cholesterol
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
The change over time from the baseline to end of treatment, both within and between the group.
Change in Apolipoprotein A-1
The change over time from the baseline to end of treatment, both within and between the group.
Change in Apolipoprotein B
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
The change over time from the baseline to end of treatment, both within and between the group.
Change in hydroxymethylglutaryl-coenzyme A
The change over time from the baseline to end of treatment, both within and between the group.
Change in Coenzyme Q10
The change over time from the baseline to end of treatment, both within and between the group.
Change in Atherogenic index of Plasma
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)
The change over time from the baseline to end of treatment, both within and between the group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479983
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arjuna Natural Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
Indian gooseberry, Total cholesterol, Triglycerides
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMX160
Arm Type
Experimental
Arm Description
500 mg (one capsule) x 2 times daily for 90 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500mg (one capsule) x 2 times daily for 90 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
AMX160
Other Intervention Name(s)
Phyllanthus emblica L., Indian Gooseberry, Emblica officinalis
Intervention Description
500 mg Phyllanthus emblica L. fresh fruit extract capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
500 mg roasted rice powder in visually identical capsules
Primary Outcome Measure Information:
Title
Change in Total Cholesterol
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Secondary Outcome Measure Information:
Title
Change in Triglycerides
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Title
Change in Low Density Lipoprotein Cholesterol
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Title
Change in High Density Lipoprotein Cholesterol
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Title
Change in Very Low Density Lipoprotein Cholesterol
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Title
Change in Triglyceride /High Density Lipoprotein Cholesterol ratio
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline, Day 45 & Day 90
Title
Change in Apolipoprotein A-1
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Apolipoprotein B
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Apolipoprotein B/Apolipoprotein A-1 Ratio
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in hydroxymethylglutaryl-coenzyme A
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Coenzyme Q10
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Atherogenic index of Plasma
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40)
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Other Pre-specified Outcome Measures:
Title
Change in Thyroid-stimulating hormone
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Homocysteine
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in High Sensitivity C-Reactive Protein
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
Title
Change in Global Physical Activity Questionnaire
Description
The change over time from the baseline to end of treatment, both within and between the group.
Time Frame
Baseline & Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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)
Family history of premature CHD (CHD in male first degree relative <55 years; CHD in female first degree relative <65 years).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binu T Kuruvilla, Dr.
Phone
91-9447818432
Email
drbinu@arjunanatural.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sooraj R
Phone
91-9847670997
Email
sooraj@arjunanatural.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamayak Sisakian, MD
Organizational Affiliation
Yerevan State Medical University, Armenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic of General and Invasive Cardiology University Hospital 1, YSMU
City
Yerevan
ZIP/Postal Code
375025
Country
Armenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Sahakyan, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing 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.
Learn more about this trial
Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
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