Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03479983
• Other study ID #: AN-06ASE 0717H4-YSM01
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: August 2019

Study information

• Verified date: January 2019
• Source: Arjuna Natural Limited
• Contact: Binu T Kuruvilla, Dr.
• Phone: 91-9447818432
• Email: drbinu[@]arjunanatural.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• AMX160
500 mg Phyllanthus emblica L. fresh fruit extract capsules
• Placebo
500 mg roasted rice powder in visually identical capsules

Locations

Country	Name	City	State
Armenia	Clinic of General and Invasive Cardiology University Hospital 1, YSMU	Yerevan

Sponsors (1)

Lead Sponsor	Collaborator
Arjuna Natural Limited

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in Homocysteine	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Apolipoprotein B	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Secondary	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
Secondary	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
Secondary	Change in Coenzyme Q10	The change over time from the baseline to end of treatment, both within and between the group.	Baseline & Day 90
Secondary	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
Secondary	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