FindTrial
Sign In

Study on the Clinical Efficacy and Mechanism of Classic Traditional Chinese Medicine Prescriptions and Their Active Component Extracts in the Treatment of Ulcerative Colitis (UC) Based on the Regulation of Intestinal Microecology

Study on the Clinical Efficacy and Mechanism of Classic Traditional Chinese Medicine Prescriptions and Their Active Component Extracts in the Treatment of Ulcerative Colitis (UC) Based on the Regulation of Intestinal Microecology

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123837
Enrollment
Unknown
Registered
2026-04-30
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Ulcerative Colitis

Interventions

Control group:Administer 1 g of Mesalazine Enteric-Coated Tablets orally four times daily for a continuous treatment period of one month.
Treatment group:Administer Mahuang Shengma Decoction, 300 mL each time, three times a day, for continuous treatment of one month.

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the relevant Western medical diagnostic criteria specified in the Expert Consensus on Inflammatory Bowel Disease Complicated with Opportunistic Infections; 2. Comply with the relevant TCM diagnostic standards in the Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Ulcerative Colitis (Draft), including yellow and greasy tongue coating, thready and rapid pulse, fever and dry mouth, scanty dark urine; 3. The frequency of diarrhea exceeds 6 times per day with mucopurulent and bloody stool; 4. All research participants are fully informed of and agree to the content of this clinical study, voluntarily participate in the trial, and have signed informed consent forms; 5. Aged 18 years or above and no more than 70 years old, with no restriction on gender.

Exclusion criteria

Exclusion criteria: 1. Those who fail to meet the requirements for inclusion criteria; 2. Patients with severe coexisting infections; 3. Patients with colorectal cancerous lesions; 4. Pregnant or lactating women; 5. Those who cannot comply with the medication requirements of this clinical trial and thus affect the trial results.

Design outcomes

Primary

MeasureTime frame
Remission rate of histopathological score (Nancy index);—

Secondary

MeasureTime frame
Boston Bowel Preparation Scale (BBPS) score;Sutherland Disease Activity Index (DAI) score;Traditional Chinese Medicine syndrome score;Serum interleukin-1ß (IL-1ß) level;Serum interleukin-4 (IL-4) level;Serum transforming growth factor-ß (TGF-ß) level;Serum matrix metalloproteinase-1 (MMP-1) level;—

Countries

China

Contacts

Public ContactChengwei Ruan

The Affiliated Hospital of Xuzhou Medical University

doctorruan666@163.com+86 516 8580 2179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026