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Efficacy of metformin hydrochloride enema in the treatment of ulcerative colitis: a multicenter randomized controlled study

Explore the curative effect of metformin hydrochloride enema on ulcerative colitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092548
Enrollment
Unknown
Registered
2024-11-19
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Ulcerative colitis

Interventions

The metformin group:Metformin hydrochloride enteric enema
Control Group:Saline enema

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1: Age 18-70 years old, gender is not limited 2: Subjects with confirmed ulcerative colitis(involving rectum and/or sigmoid) were evaluated by endoscopy, histology, and imaging 3: Subjects receiving medication 4: Patients voluntarily sign informed consent forms

Exclusion criteria

Exclusion criteria: 1: Patients with severe ulcerative colitis 2: Patients treated with systemic or rectal steroids 3: Patients known to be allergic to any investigational drug 4: Patients with liver and kidney dysfunction 5: Pregnant and lactating patients 6: Patients with a history of colorectal cancer 7: Patients with a history of total or partial colectomy 8: Current or former metformin therapy for female subjects with polycystic ovary syndrome 9: Diabetic subjects with a history of lactic acidosis, and subjects with disease status associated with hypoxemia, including cardiopulmonary insufficiency 10: Patients with positive fecal cultures for intestinal pathogens and positive tests for fecal eggs and parasites

Design outcomes

Primary

MeasureTime frame
Endoscopic score;Histological score;Improved Mayo Score;

Secondary

MeasureTime frame
ESR;CRP;Fecal calvetin;Fecal lactoferrin;

Countries

China

Contacts

Public ContactZhe Shen

The First Affiliated Hospital, College of Medicine, Zhejiang University

shenzdr@zju.edu.cn+86 136 5671 3039

Outcome results

None listed

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