Skip to content

Clinical protocol of Kuijie prescription in the treatment of active ulcerative colitis

Clinical protocol of Kuijie prescription in the treatment of active ulcerative colitis: a non-randomized multicenter prospective observational study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078272
Enrollment
Unknown
Registered
2023-12-02
Start date
2023-12-02
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Ulcerative colitis

Interventions

Mesalazine group:Mesalazine enteric-coated tablets 2 tablets three times a day orally.
combination group:Chinese medicine formula granule (Guangdong Yifang Pharmaceutical Co., Ltd, Foshan, China) will be taken one dose a day with warm water, morning and evening, combing with Mesalazine

Sponsors

Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with mild to moderate UC activity (modified Mayo score 3-10, endoscopic score >1); (2) TCM syndrome differentiation is intestinal damp-heat syndrome; (3)18-75 (inclusive) years old, voluntarily sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe complications, such as toxic mega-colon, intestinal obstruction, intestinal perforation, massive bleeding, colorectal cancer. (2) People with other intestinal diseases, such as bacillary dysentery, intestinal conjunctibles, Crohn's disease. (3) A person who is pregnant, breastfeeding or trying to become pregnant. (4) Patients with serious primary diseases such as heart, brain, lung, kidney, liver, hematopoietic system, and malignant tumors. (5) Those who are allergic to prescription ingredients or treatment contraindications. (6) Participants who have participated in other clinical trials in the past 4 weeks. (7) Others judged by the researcher to be unsuitable for the situation.

Design outcomes

Primary

MeasureTime frame
Mayo Score;

Secondary

MeasureTime frame
UCEIS;IBD-Q;TCM symptom score for gastrointestinal diseases;

Countries

China

Contacts

Public ContactXia Ding

Beijing University of Chinese Medicine

dingx@bucm.edu.cn+86 136 1118 4842

Outcome results

None listed

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