Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 suppository was given rectally once a day

    Drug

    Methalazine suppository was given rectally once a day

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Study GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Symptoms: frequency of stool

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

Time frame
Follow-up for 6 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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