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NCT Number: NCT06667934

Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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

Other names: retained enema with Zuoqing powder , once a night

Methalazine suppository was given rectally once a day

Drug

Methalazine suppository was given rectally once a day

Primary outcomes

  1. Symptoms: frequency of stool

    Time frame: Follow-up for 6 months

    Symptoms: frequency of stool in one day, or Daily number of bowel movements

Study contacts

Contact information is provided by the study sponsor or research team.

Heng Deng, Dr.

CONTACT

[email protected]

+8613335510159

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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