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Clinical evaluation of Tiaochang Xiaoyan tablet combined with Mesalamine in the treatment of mild and moderate active ulcerative colitis

Clinical evaluation of Tiaochang Xiaoyan tablet combined with Mesalamine in the treatment of mild and moderate active ulcerative colitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093130
Enrollment
Unknown
Registered
2024-11-28
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Ulcerative colitis

Interventions

Control group:The placebo of Tiaochang Xiaoyan tablets (4 tablets per time, 4 times a day, orally) and Mesalamine (2 g per time, 2 times a day, orally) were taken continuously for 12 weeks
Experimental group:Tiaochang Xiaoyan tablets (4 tablets per time, 4 times a day, orally) and Mesalamine (2 g per time, 2 times a day, orally) were taken continuously for 12 weeks

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with mild and moderate active UC; The ages of between 18 and 75; Suitable for Mesalamine treatment; Those who voluntarily participate in this study and have signed the informed consent form, the process of obtaining the informed consent form should be in accordance with ethical principles;

Exclusion criteria

Exclusion criteria: Pregnant or lactating women, or those who plan pregnancy during the study cycle. Patients with Inflammatory bowel disease has serious complications, such as local stenosis, intestinal obstruction, intestinal perforation, etc. Patients with mental disorders and mental retardation. Those who are seriously ill and need urgent treatment. Patients with severe active infections (e.g. tuberculosis, septicemia, cytomegalovirus infection, listeria infection) and opportunistic infections (e.g. progressive multifocal leukoencephalopathy). Patients who are known to be allergic to the drugs and related drug ingredients used in this study. Those who are participating in clinical trials of other drugs or who have participated in other clinical trials within 4 weeks. Patients who were treated with traditional Chinese medicine or proprietary Chinese medicine within 2 weeks, and within the half-life of 5 biological agents (such as Vidrizumab 25.5 days, enalapril 17.5 days, infliximab 50 days, adamumab 70 days, Usmumab 105 days, Skuciyou monoclonal antibody 135 days, etc.). Patients that the researchers believe are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
response rate;

Secondary

MeasureTime frame
Individual symptom score;Chinese medicine symptom complex score;Relapse rate;Endoscopic response rate and mucosal healing rate;

Countries

China

Contacts

Public ContactZhang Haiyan

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

zhanghaiyan128@126.com+86 138 2448 2735

Outcome results

None listed

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