Status:
UNKNOWN
Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
Lead Sponsor:
Arjuna Natural Limited
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
NA
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 hypercho...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
June 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2019
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT03479983
Start Date
June 4 2018
End Date
August 1 2019
Last Update
January 10 2019
Active Locations (1)
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1
Clinic of General and Invasive Cardiology University Hospital 1, YSMU
Yerevan, Armenia, 375025