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Clinical Efficacy Evaluation Study of Kuijie Core Formula Combined with Mesalazine in Patients with Ulcerative Colitis of the Large Intestine Dampness-Heat Pattern

Clinical Efficacy Evaluation Study of Kuijie Core Formula Combined with Mesalazine in Patients with Ulcerative Colitis of the Large Intestine Dampness-Heat Pattern

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001113
Enrollment
Unknown
Registered
2025-06-03
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Ulcerative Colitis

Interventions

Experimental group:Kuijie Core Formula + mesalazine

Sponsors

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1)Underwent electronic colonoscopy within the past 3 months and met the diagnostic criteria for UC with the Large Intestine Dampness-Heat Pattern. (2)No gender restriction; aged 18–70 years with no history of intestinal surgery. (3)In the active phase of ulcerative colitis with a Mayo score of 3–12 points. (4)Good patient compliance able to understand the study details and provide informed consent approved by the hospital's ethics committee.

Exclusion criteria

Exclusion criteria: (1)Patients with infectious colitis such as intestinal tuberculosis bacterial dysentery etc. (2)Patients with complications requiring surgical treatment such as intestinal perforation intestinal obstruction intestinal stenosis or malignancy . (3)Pregnant or breastfeeding women. (4)Patients with severe acute or chronic diseases such as acute myocardial infarction acute pancreatitis stroke heart failure Lynch syndrome malignancies etc. . (5)Patients with allergic constitution or known allergies to the components of the study medication. (6)Patients with language or intellectual disabilities or other reasons that may prevent cooperation with the study and follow-up. (7)Patients currently participating in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Clinical Efficacy Evaluation;

Secondary

MeasureTime frame
Modified Mayo Score;IBDQ;Inflammatory-Related Factors;Intestinal Mucosal Barrier;Intestinal Mucosal Healing Rate;Efficacy Evaluation of Traditional Chinese Medicine (TCM) Syndromes;C-Reactive Protein to Albumin Ratio (CAR);

Countries

China

Contacts

Public ContactYang Wei

Shuguang Hospital Affiliated with Shanghai University of traditional Chinese Medicine

yangweiyishi@163.com+86 139 1719 8396

Outcome results

None listed

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