A Phase 1/2 interventional study of Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night and Methalazine suppository was given rectally once a day in Ulcerative Colitis (UC), sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Phase 1/2, Interventional, and Treatment
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.
1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.
Browse Colitis, Ulcerative studies →The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Inclusion Criteria:① Clinically diagnosed UC; ② The severity of UC is mild to moderate.
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Exclusion Criteria:① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.
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Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Methalazine supposers anal once a day
Drug: Methalazine suppository was given rectally once a day
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Also known as: retained enema with Zuoqing powder , once a night
Methalazine suppository was given rectally once a day
Symptoms: frequency of stool
Symptoms: frequency of stool in one day, or Daily number of bowel movements
Time frame: Follow-up for 6 months
No study locations are listed for this record.
Plan to share: Yes — We can share IPD with other researchers. When our research results are phased, other research groups can watch and participate in the discussion of the research plan.
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine