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A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis

A multicenter randomized controlled trial for Shi-Xiao-San Powder and Er-Zhi-Wan Pill in the treatment of primary biliary cirrhosis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900027043
Enrollment
Unknown
Registered
2019-10-29
Start date
2019-11-30
Completion date
Unknown
Last updated
2020-09-07

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

Conditions

primary biliary cirrhosis

Interventions

Sponsors

Longhua Hospital, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) signing the informed consent; (2) male or female aged 18-65 years; (3) the syndrome differentiation of traditional Chinese medicine is liver kidney yin deficiency, blood stasis blocking collaterals; (4) patients whose clinical diagnosis of Western medicine conforms to the PBC diagnostic standard and belongs to stage II and III;

Exclusion criteria

Exclusion criteria: (1) Combined with drug-induced liver injury, autoimmune hepatitis A, B, C, e, etc.; (2) patients with serious primary diseases of heart, brain, kidney, lung, endocrine, blood, metabolism and gastrointestinal tract, or psychosis; (3) creatinine (CR) is higher than the upper limit of normal value; (4) those who use drugs to lose weight; (5) an alcoholic or drug addict; (6) pregnant women, lactating women or those who prepare for pregnancy in the near future and those who use estrogen for contraception; (7) those who are allergic to a variety of drugs, this medicine or its components; (8) the patient is in critical condition, and it is difficult to make accurate evaluation on the effectiveness and safety of the new drug; (9) patients are not willing to cooperate.

Design outcomes

Primary

MeasureTime frame
Clinical efficiency;Clinical symptom score ;liver function;Four items of liver fibrosis ;AMA;AMA-M2;GLOBE-Score;APRI??;Fibrotouch;

Countries

China

Contacts

Public ContactXing Lianjun

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

xingdoctor@126.com+86 13610661366

Outcome results

None listed

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