Critical State of "Remission-Recurrence" of Ulcerative Colitis (CSRRUC)

November 15, 2024 updated by: Shengsheng Zhang, Beijing Hospital of Traditional Chinese Medicine

Research on the Biological Basis of "Disease-Syndrome-Formula" in the Critical State of "Remission-Recurrence" of Ulcerative Colitis (Joint Application A)

This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety self-assessment scale, depression self-assessment scale, etc., every month. Collect blood, urine, and stool samples from patients every month for examination. Follow up for each subject until their condition recurs.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

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

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Dongcheng, Beijing, China, 100010
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Visited the Digestive Department Outpatient Department of Beijing Hospital of Traditional Chinese Medicine

Description

Inclusion Criteria:

  • Patients who meet the criteria based on the clinical characteristics of ulcerative colitis patients in the "remission recurrence" critical state, combined with clinical symptoms, are diagnosed with ulcerative colitis through imaging, endoscopy, laboratory, and histopathological examinations;
  • Patients with comprehensive laboratory testing indicators.

Exclusion Criteria:

  • Patients with incomplete case information records;
  • Patients who have not completed serological tests;
  • Complications including intestinal obstruction, intestinal perforation, toxic megacolon, and severe local stenosis;
  • Diagnosed or suspected patients with coexisting uncertain colitis, infectious or ischemic colitis;
  • Patients with coexisting local or systemic infections, any malignant diseases, or autoimmune diseases;
  • Merge primary diseases such as respiratory, circulatory, neurological, endocrine, and hematological disorders;
  • Individuals at risk of developing cancer;
  • regnant or lactating women.

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

Cohorts and Interventions

Group / Cohort
Ulcerative colitis in remission period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recurrence rate of patients
Time Frame: The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process
The recurrence rate of 100 follow-up patients was counted at the end of the follow-up period
The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process

Collaborators and Investigators

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

Sponsor

Beijing Hospital of Traditional Chinese Medicine

Investigators

  • Principal Investigator: Shengsheng Zhang, Doctor, Beijing Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 19, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 3, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Estimated)

November 19, 2024

Study Record Updates

Last Update Posted (Estimated)

November 19, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82341235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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