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Clinical study on the treatment of cholestatic jaundice with Kuhuang granules

A prospective, open label, positive drug controlled clinical trial of Kuhuang granules in the treatment of cholestatic jaundice

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087059
Enrollment
Unknown
Registered
2024-07-18
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

cholestatic jaundice

Interventions

Experimental group:Kuhuang granules

Sponsors

Dengzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18-80 years old (including threshold), gender not limited. 2. According to the "Guidelines for the Management of Cholestasis Liver Disease (2021)" and the "Guidelines for the Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine - Western Medicine Diseases", the diagnosis is cholestatic liver disease with damp heat syndrome of the liver and gallbladder. 3. Clear consciousness and generally stable vital signs. 4. Understand the entire process of the experiment, voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with special cholestatic liver diseases such as FIC1, 2, 4, 5, 6, USP53 deficiency, IFC3, Alagille syndrome, Citrin deficiency, bile duct plate developmental abnormalities (Caroli's disease and congenital and cystic liver fibrosis), and Niemann Pick's disease (C1/C2 type); (2) Patients with combined genetic factors and hemolytic diseases such as hereditary hyperbilirubinemia (Gilbert syndrome, Crigler Najjar syndrome, Dubin Johnson syndrome, and Rotor syndrome, etc.), hereditary spherocytosis, thalassemia, paroxysmal nocturnal hemoglobinuria, and acquired hemolytic anemia; (3) 2 weeks before randomization, treatment that affects the efficacy of this study, such as taking bile acid chelate mixture to treat severe itching, taking rifampicin to treat tuberculosis, etc. (4) patients with known ingredients of the test drug or allergic constitution, and those who cannot accept the treatment of this scheme; (5) Pregnant or pregnant women, lactating women; (6) The researchers believe that the subjects are not suitable to participate in any other situation or condition in this study, including other serious diseases, serious laboratory test abnormalities, or the presence of two or more diseases that cause cholestatic jaundice in patients, or factors that affect the safety of the subjects, or factors that affect the collection of experimental data and samples, such as family or social factors.

Design outcomes

Primary

MeasureTime frame
Effective rate after treatment;

Secondary

MeasureTime frame
Absolute changes in blood biochemical indicators relative to baseline after treatment;Absolute changes in coagulation function indicators relative to baseline after treatment;Absolute changes in traditional Chinese medicine syndrome scores relative to baseline;During the treatment period, all adverse reactions occurred;

Countries

China

Contacts

Public ContactBashuli

Dengzhou Central Hospital

13598280988@126.com+86 135 9828 0988

Outcome results

None listed

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