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Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06667934
Enrollment
60
Registered
2024-10-31
Start date
2024-10-30
Completion date
2025-05-01
Last updated
2024-10-31

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

Conditions

Ulcerative Colitis (UC)

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.

Interventions

DRUGZuoqing 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

DRUGMethalazine suppository was given rectally once a day

Methalazine suppository was given rectally once a day

Sponsors

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

① Clinically diagnosed UC; ② The severity of UC is mild to moderate. \-

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. \-

Design outcomes

Primary

MeasureTime frameDescription
Symptoms: frequency of stoolFollow-up for 6 monthsSymptoms: frequency of stool in one day, or Daily number of bowel movements

Contacts

Primary ContactHeng Deng, Dr.
dengheng23@outlook.com+8613335510159

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026