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Prospective Open-label Non-inferiority Clinical Observation of Modified P us-Draining Powder in the Treatment of Ulcerative Colitis

Prospective Open-label Non-inferiority Clinical Observation of Modified P us-Draining Powder in the Treatment of Ulcerative Colitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000664
Enrollment
Unknown
Registered
2025-04-06
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Ulcerative colitis

Interventions

Experimental group:Oral mesalazine sustained-release granules combined with improved formula of Tounong San
Control group:Oral mesalazine sustained-release granules

Sponsors

Chengdu Hospital of Integrated Traditional Chinese and Western Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria for mild to moderate ulcerative colitis as per the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (2018 Beijing)" 2) Refer to the "Guidelines for Clinical Research of New Traditional Chinese Medicines" to formulate the Qi Deficiency and Blood Stasis type of ulcerative colitis 3) Aged =18 years and not exceeding 75 years 4) The subject (including male subjects) or their spouse/partner has no pregnancy plans in the next 12 months 5) Good communication skills and no allergic reactions to the drugs used in this study 6) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with severe ulcerative colitis; 2) Those currently using other traditional Chinese medicines; 3) Pregnant or breastfeeding subjects; 4) Subjects who have used immunosuppressants in the past 6 months of treatment; 5) Subjects with severe complications such as localized intestinal stricture intestinal obstruction intestinal perforation toxic megacolon colon cancer etc.; 6) Ulcerative colitis accompanied by primary diseases such as cardiovascular cerebrovascular liver kidney or blood diseases; 7) Those intolerant to colonoscopy.

Design outcomes

Primary

MeasureTime frame
calprotectin;colorectal endoscopy;

Secondary

MeasureTime frame
C-reactive protein;Interleukin-1ß;hemoglobin;erythrocyte sedimentation rate;Interleukin-10S;TNF-a;

Countries

China

Contacts

Public ContactXudong Wen

Chengdu Hospital of Integrated TCM and Western Medicine

xudongwen@cdutcm.edu.cn+86 136 4803 5311

Outcome results

None listed

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