Effect of Indian Gooseberry Extract (AMX160) in Hypercholesterolemia
关键词
抽象
描述
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.
日期
| 最后验证: | 12/31/2018 |
| 首次提交: | 03/20/2018 |
| 提交的预估入学人数: | 03/20/2018 |
| 首次发布: | 03/26/2018 |
| 上次提交的更新: | 01/08/2019 |
| 最近更新发布: | 01/09/2019 |
| 实际学习开始日期: | 06/03/2018 |
| 预计主要完成日期: | 04/30/2019 |
| 预计完成日期: | 07/31/2019 |
状况或疾病
干预/治疗
Dietary Supplement: AMX160
Dietary Supplement: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| 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 |
| 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 |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | 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). |
结果
主要结果指标
1. Change in Total Cholesterol [Baseline, Day 45 & Day 90]
次要成果指标
1. Change in Triglycerides [Baseline, Day 45 & Day 90]
2. Change in Low Density Lipoprotein Cholesterol [Baseline, Day 45 & Day 90]
3. Change in High Density Lipoprotein Cholesterol [Baseline, Day 45 & Day 90]
4. Change in Very Low Density Lipoprotein Cholesterol [Baseline, Day 45 & Day 90]
5. Change in Triglyceride /High Density Lipoprotein Cholesterol ratio [Baseline, Day 45 & Day 90]
6. Change in Apolipoprotein A-1 [Baseline & Day 90]
7. Change in Apolipoprotein B [Baseline & Day 90]
8. Change in Apolipoprotein B/Apolipoprotein A-1 Ratio [Baseline & Day 90]
9. Change in hydroxymethylglutaryl-coenzyme A [Baseline & Day 90]
10. Change in Coenzyme Q10 [Baseline & Day 90]
11. Change in Atherogenic index of Plasma [Baseline & Day 90]
12. Change in Adult Treatment Panel III goal (Triglyceride < 150 mg/dL, LDL < 100 mg/dL, HDL > 40) [Baseline & Day 90]
其他成果措施
1. Change in Thyroid-stimulating hormone [Baseline & Day 90]
2. Change in Homocysteine [Baseline & Day 90]
3. Change in High Sensitivity C-Reactive Protein [Baseline & Day 90]
4. Change in Global Physical Activity Questionnaire [Baseline & Day 90]
