NCT06667934

Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.

Conditions

• Ulcerative Colitis (UC)

Interventions

Type	Name	Description
DRUG	Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night	Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
DRUG	Methalazine suppository was given rectally once a day	Methalazine suppository was given rectally once a day

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-10-31
• Last updated: 2024-10-31