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

NCT05780723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-12-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Hospital of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Luqing Zhao, Doctor · Beijing Hospital of Traditional Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2024-10-23
Completion
2024-10-23

Countries

  • China

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05780723 on ClinicalTrials.gov