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NOT YET RECRUITING
NCT06667934
PHASE1/PHASE2

Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

Sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-10-30

Completion Date

2025-05-01

Last Updated

2024-10-31

Healthy Volunteers

No

Interventions

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