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A Randomized Controlled Clinical Trial of Jianpi Huashi Bushen Formula in the Treatment of Patients with Ulcerative Colitis

A Randomized Controlled Clinical Trial of Jianpi Huashi Bushen Formula in the Treatment of Patients with Ulcerative Colitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001031
Enrollment
Unknown
Registered
2026-04-20
Start date
2025-12-25
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Ulcerative colitis

Interventions

Treatment group:Jianpi Huashi Bushen Formula

Sponsors

Shuguang Hospital affiliated to Shanghai University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years 2. Clinical diagnosis of ulcerative colitis 3. TCM syndrome conforming to spleen-kidney yang deficiency type 4.Signed informed consent, good compliance with researchers' observations and treatments, voluntary participation.

Exclusion criteria

Exclusion criteria: 1)Intestinal inflammatory diseases caused by other reasons: infectious colitis (bacillary dysentery, amoebic dysentery, chronic schistosomiasis, intestinal tuberculosis, etc.), Crohn's disease, ischemic colitis, radiation colitis, high-grade intraepithelial neoplasia rectal lesions, or patients with positive fecal viral/bacterial tests (Shigella, Salmonella, Campylobacter, Yersinia, E. coli, etc.); 2) Severe underlying diseases (cardiovascular, hepatic, renal, pulmonary, etc.) or other serious complications; 3) Severe gastrointestinal diseases: toxic megacolon, gastrointestinal tumors, perforation, massive bleeding, intestinal obstruction, etc.; 4) Severe mental disorders or communication barriers preventing cooperation; 5) Pregnant/lactating women, those planning pregnancy, or patients allergic to study medications; 6) Patients using medications incompatible with Asacol (thioguanine, mercaptopurine, ampicillin, probenecid, warfarin, methotrexate, folic acid, etc.) within 1 week, or those receiving varicella vaccine/steroid medications (prednisone, etc.); 7) Participation in other clinical trials within 1 month; 8) Biologic agent use within 1 month; 9) Severe allergy or hypersensitivity to Asacol/TCM components.

Design outcomes

Primary

MeasureTime frame
Improved Mayo score;

Secondary

MeasureTime frame
Baron endoscopic score;Effectiveness of Traditional Chinese Medicine Syndromes;IBDQ inflammatory bowel disease quality of life score;UC-SQ ulcerative colitis symptom score;Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score;Geboes score;Modified Truelove and Witts Disease Severity Classification;fecal calprotectin;cytokine;Erythrocyte Sedimentation Rate;C-reactive protein;Vitamin D;Coagulation Function;

Countries

China

Contacts

Public ContactWei-Wei Hao

Shuguang Hospital affiliated to Shanghai University of TCM

876421799@qq.com15621736859

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026