Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
2 other identifiers
interventional
60
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2024
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2024
CompletedStudy Start
First participant enrolled
October 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedOctober 31, 2024
October 1, 2024
6 months
October 29, 2024
October 30, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Symptoms: frequency of stool
Symptoms: frequency of stool in one day, or Daily number of bowel movements
Follow-up for 6 months
Study Arms (2)
Study Group
EXPERIMENTALZuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Control Group
ACTIVE COMPARATORMethalazine supposers anal once a day
Interventions
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Methalazine suppository was given rectally once a day
Eligibility Criteria
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Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
October 29, 2024
First Posted
October 31, 2024
Study Start
October 30, 2024
Primary Completion
May 1, 2025
Study Completion
May 1, 2025
Last Updated
October 31, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
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.