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Danning tablets combined with ursodeoxycholic acid in the management of cholestatic liver diseases of damp heat stagnation type

Study on the regulation of bile acids by Danning tablets in cholestatic liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000121
Enrollment
Unknown
Registered
2025-01-15
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

cholestatic diseases

Interventions

Experimental group:Danning tablets combined with ursodeoxycholic acid

Sponsors

Hunan Provincial People Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Inpatients who sign informed consent forms; (2) Age range: 18-65 years old gender not limited; (3) ALP exceeds the normal upper limit by 1.5 times and GGT exceeds the normal upper limit by 3 times; (4) According to traditional Chinese medicine it is classified as damp heat stagnation type: meeting two criteria (jaundice rib pain bitter mouth yellow urine constipation); Satisfy 1 condition (pale red tongue thin yellow and greasy tongue coating number of wet veins); (5) Individuals with good main organ function and able to tolerate treatment; (6) Good compliance family members willing to cooperate with follow-up.

Exclusion criteria

Exclusion criteria: (1) Combination of pharmacologic liver injury autoimmune hepatitis viral hepatitis A B C and E; (2) Patients with combined liver cancer hepatic encephalopathy as well as severe primary diseases of the heart brain kidneys lungs endocrine system blood metabolism and gastrointestinal tract or psychiatric patients; (3) Individuals with creatinine (Cr) levels exceeding the upper limit of normal range; (4) Individuals who use medication for weight loss alcoholism or drug addiction; (5) According to traditional Chinese medicine it is classified as non damp heat stagnation type; (6) Pregnant women breastfeeding women or those preparing to conceive in the near future as well as those using estrogen contraception; (7) Individuals with allergic constitution and allergies to multiple drugs as well as components of this medicine or prescription; (8) Those with critical illness who find it difficult to accurately evaluate the effectiveness and safety of drugs; (9) Patients are unwilling to cooperate with partners; (10) Individuals with mental illnesses who cannot cooperate with regular medication.

Design outcomes

Primary

MeasureTime frame
Immunoglobulin M;liver function;total cholesterol;

Secondary

MeasureTime frame
hyaluronidase;Type III procollagen;liver fibrosis indicators;laminin;liver stiffness;Type IV collagen;

Countries

China

Contacts

Public ContactYa Peng

Hunan Provincial People Hospital

pengya123@hunnu.edu.cn+86 135 7415 9343

Outcome results

None listed

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