CTRI/2022/06/043558已完成未知
A randomized, double blind, placebo controlled clinical trial to evaluate the efficacy and safety of MXP22 on liver health
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 59
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Adult men and women aged =30 and =60 years, diagnosed with NAFLD within last 2 years.
- •2. CAP scores =248 and =270 dB/m indicating steatosis grade I/ II.
- •3. Non-alcoholics (little or no consumption of alcohol).
- •4. Willing to participate in the study with a signed and dated written consent.
- •5. Overweight and obese participant with BMI =25 kg/m2.
- •6. Having at least 3 of the following five metabolic risk factors:
- •i Waist circumference: Men: = 102 cm (40.15 inches); Women =88 cm (34.65 inches).
- •ii Triglycerides >150 mg/dL.
- •iii Blood pressure =130 mm Hg (systolic, SBP) and/or =85 mm Hg (diastolic, DBP).
- •iv Fasting blood glucose = 100 mg/ dl.
- •v Low HDL level: Men: < 40 mg/dL; Women: < 50 mg/dL.
排除标准
- •1. Treatment of NAFLD for at least 3 months prior to the screening.
- •2. History of decompensated liver disease (ascites, encephalopathy, variceal bleeding).
- •3. Participants with liver cirrhosis, any concomitant liver disease.
- •4. Participants with systemic inflammatory disease or autoimmune disorders.
- •5. Participants with blood pressure =160 mm Hg (systolic, SBP) and/or =95 mm Hg (diastolic, DBP).
- •6. Participants with Fasting blood glucose = 140 mg/ dl.
- •7. Participants with cardiopulmonary disease.
- •8. Heavy alcohol drinkers defined as follows:
- •i For men, consuming more than 4 drinks on any day or more than 14 drinks/week
- •ii For women, consuming more than 3 drinks on any day or more than 7 drinks/week
- •9. Participants with liver cancer - primary hepatocellular carcinoma or liver metastasis.
- •10. Participants with other systemic disorders of the heart, lungs, blood, and endocrine system, including thyroid dysfunction and Type I diabetes mellitus.
- •11. Histologic evidence of NASH with fibrosis stage (METAVIR score) F1 or F4.
- •12. Individuals with Inflammatory bowel diseases.
- •13. Use of medications containing systemic steroids, methotrexate corticosteroids, amiodarone, tamoxifen, valproate, vitamin E, omega-3, Anti-retroviral agents; 1 month prior to screening.
- •14. Intake of probiotics (lactic acid bacteria, etc.), prebiotics (dietary fiber, fructooligosaccharide, etc.), new biotics, fermented milk and proton pump inhibitor within one month before screening or during the study period.
- •15. Participants who have hypersensitivity to the test drug/ placebo or components contained in the test drug/placebo or have severe allergic reactions.
- •16. Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
- •17. Regular use of a probiotic or prebiotic supplement within 3 months prior to screening.
- •18. Antibiotic use within 3 weeks prior to screening.
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