Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night; Drug: Methalazine suppository was given rectally once a day

Study type: Interventional

Funder types: Other

Identifiers

NCT06667934

2024AH-98-01

2021AH9987 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Study Group

Experimental group

Description:

Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Treatment:

Drug: Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night

Control Group

Active Comparator group

Description:

Methalazine supposers anal once a day

Treatment:

Drug: Methalazine suppository was given rectally once a day