NCT05780723

Treatment of Ulcerative Colitis With Rectal Instillation of Qinghua Quyu Prescription(QHQYP)

A Randomized Controlled Study of Qinghua Quyu Prescription Rectal Instillation for the Treatment of Ulcerative Colitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beijing Hospital of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll 60 patients with mild to moderate active ulcerative colitis as subjects. They will be randomly divided into two groups: the TCM group received QHQYP rectal instillation, while the control group received mesalazine enema. The treatment period for both groups was 8 weeks. The modified Mayo Activity Index will be used as the main evaluation index. Secondary evaluation indices will include the Underwater Endoscopic Severity Index (UCEIS) score, endoscopic Baron score, mucosal histological score (Geboes index), Chinese medicine syndrome efficacy evaluation, quality of life score, physicochemical indicators reflecting disease activity or remission, intestinal microbiota indicators, and changes in inflammation and immune-related indicators in colonoscopy biopsy tissues. Safety indicators were also monitored.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Treatment group: Rectal instillation of QHQYP	QHQYP is decocted in water, with a dose of 100ml each time, and rectal drip before going to bed, once a night, for 8 weeks.
DRUG	Control group: Mesalazine enema treatment	Mesalazine enema, 4g/tube, 1 tube each time, enema before bed, once a night, a total of 8 weeks of continuous treatment.

Timeline

• Start date: 2023-04-04
• Primary completion: 2024-10-23
• Completion: 2024-10-23
• First posted: 2023-03-22
• Last updated: 2024-12-18

Locations

1 site across 1 country: China