Ulcerative colitis
Conditions
Interventions
Treatment group:Zhihuang Decoction Granules plus standard treatment with mesalazine sustained-release tablets (1 g per dose, four times daily, for a total treatment duration of 8 weeks)
Placebo control group:Placebo plus standard treatment with mesalazine sustained-release tablets (1 g per dose, four times daily, for a total treatment duration of 8 weeks)
Sponsors
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Meet the Western medicine diagnostic criteria for ulcerative colitis as outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023, Xi'an)", and be diagnosed with mild or moderate active ulcerative colitis; 2. Meet the Traditional Chinese Medicine (TCM) and integrated TCM-Western medicine diagnostic criteria for ulcerative colitis as described in the "Expert Consensus on TCM Diagnosis and Treatment of Ulcerative Colitis (2023)" and the "Expert Consensus on Integrated TCM-Western Medicine Diagnosis and Treatment of Ulcerative Colitis (2023)", with TCM syndrome differentiation classified as damp-heat accumulation in the intestine type of ulcerative colitis; 3.Aged between 18 and 75 years; 4.Capable of long-term follow-up; 5.Willing to participate, fully understand, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with serious complications, including local stricture, intestinal obstruction, intestinal perforation, rectal polyps, toxic megacolon, colorectal cancer, or anorectal diseases; 2.Patients who have received antibiotics, probiotics, or biologic therapy within the preceding 1 month; 3.Women who are pregnant, planning to become pregnant, or currently breastfeeding; 4.Patients with allergic constitution or known hypersensitivity to any component of the study drug; 5.Patients with severe primary diseases involving the liver, kidney, hematopoietic system, or endocrine system, as well as those with psychiatric disorders; 6.Patients who participated in other clinical trials within 3 months prior to enrollment, or those deemed ineligible by the investigator for any other reason; 7.Patients with incomplete data, including demographic information, family history, personal history, past medical history, or medication history; 8.Patients with critical illness in whom a reliable assessment of drug efficacy and safety cannot be made.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission rate; UC relapse rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ulcerative Colitis Endoscopic Index of Severity (UCEIS);Geboes Histological Score for Ulcerative Colitis (UC) Mucosal Histology;Traditional Chinese Medicine (TCM) Syndrome Score;Evaluation of patients' quality of life;Laboratory Parameters - High-Sensitivity C-Reactive Protein (hs-CRP);Laboratory Parameters - Erythrocyte Sedimentation Rate (ESR);Laboratory Parameters - Fecal Occult Blood;Laboratory Parameters - Fecal Calprotectin;Pro-inflammatory Cytokines - Interleukin-17A ;Pro-inflammatory Cytokines - tumor Necrosis Factor-alpha ;Pro-inflammatory Cytokines - interleukin-1 Beta;Anti-inflammatory Cytokine - interleukin-10;Metagenomic Sequencing;Untargeted Metabolomics Analysis;Single-cell RNA Sequencing; | — |
Countries
China
Contacts
Public ContactYingchao Liu
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed