Status:
NOT_YET_RECRUITING
Effects of Compound Probiotics-Polygonatum Sibiricum on Liver Health and Metabolism in Middle-aged and Elderly People
Lead Sponsor:
Wecare Probiotics Co., Ltd.
Conditions:
Fatty Liver
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
The purpose of this study was to evaluate the regulatory effects of Huangqian-biobacteria compound preparation on liver health and related metabolic disorders in middle-aged and elderly people, observ...
Eligibility Criteria
Inclusion
- 1\. The age of the subjects is 40-80 years old; 2. The subject meets one of the following metabolic disease components: ① abdominal B - ultrasound shows fatty liver or fat infiltration; ② arterial blood pressure is higher than 130/85mmHg, or the subject is on antihypertensive treatment; ③ prediabetes or type 2 diabetes, with fasting blood glucose above 6.1mmol/L; ④ overweight or obesity, with BMI of 24.0kg/m² or more, or male waist circumference of 90cm or more, female waist circumference of 85cm or more, or excessive body fat content and percentage.
- \-
Exclusion
- People who are allergic to any of the pharmaceutical ingredients used in this study; A history of alcohol abuse (drinking more than 14 units of alcohol per week :1 unit = 285mL for beer, 25mL for spirits, 100mL for wine);
- Patients who received probiotics within 1 month before taking the experimental drug;
- Recent history of gastrointestinal bleeding, obstruction, perforation, tumor and other serious organic diseases;
- Aminotransferase index \> 3 times the normal value;
- Kidney disease (creatinine index higher than normal);
- Patients with serious psychological and mental diseases, resulting in the inability to express themselves normally;
- Patients with infectious liver diseases, such as hepatitis B and C;
- The female subject is breastfeeding or has a positive pregnancy test result during the screening period or during the test -
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06873412
Start Date
March 10 2025
End Date
December 1 2026
Last Update
March 12 2025
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