Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis

October 30, 2024 updated by: Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study Group
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
Zuoqing powder was dissolved in 100ml normal saline, retained enema, once a night
Other Names:
  • retained enema with Zuoqing powder , once a night
Active Comparator: Control Group
Methalazine supposers anal once a day
Drug: Methalazine suppository was given rectally once a day
Methalazine suppository was given rectally once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms: frequency of stool
Time Frame: Follow-up for 6 months
Symptoms: frequency of stool in one day, or Daily number of bowel movements
Follow-up for 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 30, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024AH-98-01
  • 2021AH9987 (Other Identifier: Anhui Province key specialist project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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