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Evaluating clinical efficacy and safety of anti-dampness prescription in controlling recurrence of ulcerative colitis

Evaluating clinical efficacy and safety of anti-dampness prescription in controlling recurrence of ulcerative colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000810
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-09-11
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Ulcerative colitis

Interventions

Group treated with dispelling dampness prescription:Treating with dispelling dampness prescription
Group treated with dispelling dampness prescription placebo:Treating with dispelling dampness prescription placebo

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: 1: Patients diagnosed with moderate and severe active UC 2: The ages of between 18 and 75 3: Diagnosed as dampness syndrome based on the Evaluation scale of dampness Syndrome of traditional Chinese Medicine 4: Suitable for Vedolizumab treatment 5: 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: 1: Pregnant or lactating women or those who plan pregnancy during the study cycle. 2: Patients with Inflammatory bowel disease has serious complications such as local stenosis intestinal obstruction intestinal perforation etc. 3: Patients with mental disorders and mental retardation. 4: Those who are seriously ill and need urgent treatment. 5: Patients with severe active infections (e.g. tuberculosis septicemia cytomegalovirus infection listeria infection) and opportunistic infections (e.g. progressive multifocal leukoencephalopathy). 6: Patients who are known to be allergic to the drugs and related drug ingredients used in this study. 7: Those who are participating in clinical trials of other drugs or who have participated in other clinical trials within 4 weeks. 8: 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.). 9: Patients that the researchers believe are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Relapse rate;

Secondary

MeasureTime frame
Chinese medicine symptom complex score;Quality of life assessment;Mucosal healing rate;Endoscopic response rate;Individual symptom score;

Countries

China

Contacts

Public ContactZhang Beiping

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

doctorzbp@163.com13602762766

Outcome results

None listed

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