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A Study on the Efficacy and Safety of Mycophenolic Sulfone Capsules in Improving Liver Function

A Study on the Efficacy and Safety of Mycophenolic Sulfone Capsules in Improving Liver Function

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093739
Enrollment
Unknown
Registered
2024-12-11
Start date
2024-12-11
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gene ? Biotechnology Co., Ltd.

Interventions

test group :Take ergothioneine capsules, 2 capsules daily, 2 capsules at a time or 1 capsule in the morning and 1 capsule in the evening for 30 consecutive days.

Sponsors

Qingdao Central Hospital,University of Health and Rehabilitation Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years old, gender is not limited; 2. Willing to obey the doctor's intervention plan and cooperate with the follow-up, give informed consent and sign the informed consent form; 3. Regular life and meals, stable weight in the past three months; 4. Abnormal levels of aspartate aminotransferase (AST), alanine aminotransferase-alanine aminotransferase (ALT), ?-glutamyltransferase (GGT) and alkaline phosphatase ALP in serum were abnormal: abnormal range of AST: 40U/L <AST<200U/L; ALT abnormality range: 40 U/L in males< 200 U/L < 35 U/L in males< 175 U/L in females< GGT anomaly range: 50U/L<GGT<100U/L; ALP anomaly range: 110U/L < ALP<220U/L; 5. Subjects who are judged by the gastroenterologist to be suitable for participating in this program after the gastroenterologist's assessment of the subject's condition and related indicators, including aspartate aminotransferase (AST), alanine aminotransferase-alanine aminotransferase (ALT) levels, ?-glutamyl transferase (GGT), and alkaline phosphatase ALP.

Exclusion criteria

Exclusion criteria: 1. Patients with serious diseases of the heart, liver (viral hepatitis, liver cirrhosis), kidney and hematopoietic system, and mental illness; 2.Taking drugs or supplements known to affect fatty liver and body fat in the past 1 month; 3.Those who are allergic to the ingredients of the test product; 4. Women who are pregnant, planning to become pregnant, or breastfeeding; 5. Exclude patients with elevated ALP levels caused by bone diseases, rickets and osteomalacia, fibrous osteitis, osteoporosis, bone tumors, fracture healing, hyperparathyroidism, rheumatoid arthritis, and osteitis deformities; 6. Those who cannot abstain from alcohol during the test; 7. Clinically significant patients with abnormal results of vital signs monitoring, physical examination, clinical laboratory tests (blood routine, urine routine), urine pregnancy examination (female only), and viral hepatitis; 8. Those who have participated in or are participating in other clinical studies in the last 3 months; 9. Those who are judged by the investigator to be inappropriate to participate in this trial or who are prone to loss to follow-up.

Design outcomes

Primary

MeasureTime frame
Serum liver function biomarkers (serum aspartate aminotransferase-aspartate aminotransferase (AST), alanine aminotransferase-alanine aminotransferase (ALT), serum ?-glutamyl transferase (GGT), alkaline phosphatase (ALP), serum total bilirubin (TBil));Liver synthesis function index (total protein (TP), albumin (ALB));Clinical efficacy self-rating scale;Pittsburgh Sleep Quality Index Scale;Lipids (total triglycerides, total cholesterol, HDL, and LDL);

Countries

China

Contacts

Public ContactZhou xuefeng

Qingdao Central Hospital,University of Health and Rehabilitation Sciences

Liufj1986@126.com+86 185 6185 8205

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026