Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

March 9, 2026 updated by: Yi Zhang

Clinical Study of Moxibustion for the Prevention of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation

This study was a prospective, multicenter, randomized controlled clinical study planned to recruit 266 hematological patients with allogeneic hematopoietic stem cell transplantation (allo-HSCT), who were randomly divided into two groups according to gender, type of transplantation, and type of primary disease. The control group was treated conventionally, and the experimental group increased moxibustion of Zhongji, Guanyuan and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation. Urine routine tests were performed at the time of admission, +1d, and +14d, and urine BK virus, JC virus, and adenovirus were tested at four time points, namely, +1d, +14 days, onset of hematuria symptoms, and remission of HC, respectively; routine urine tests were performed once every 7 days for all patients within 100days. For patients with Hemorrhagic cystitis (HC), daily severity grading, pain scoring, cystitis symptom scoring, use of antispasmodic and analgesic medications, and major TCM evidence were recorded with the aim of evaluating the efficacy of moxibustion in the prevention of HC in this patient population.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

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 Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450002
        • Recruiting
        • Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou
        • Contact:
          • Ran Zhang
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Yi Zhang
        • Contact:
          • Yi Zhang
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • Hematology Department, The First People's Hospital of Yunnan
        • Contact:
          • jie Zhao
    • Zhejiang
      • Hangzhou, Zhejiang, China, 311121
        • Not yet recruiting
        • Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
        • Contact:
          • Yanmin Zhao

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
  2. Age: 14-60 years;
  3. Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia (Severe aplastic anemia; severeaplasticanimin, SAA) undergoing allo-HSCT;

Exclusion Criteria:

  1. refuse to participate in this clinical study;
  2. The corresponding skin at the moxibustion site is broken or sensitive;
  3. allo-HSCT pretreated with the RIC program;

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Symptomatic treatment
The control group received conventional symptomatic treatment.
Experimental: Moxibustion
Other: Moxibustion
The experimental group received moxibustion of Zhongji, Guanyuan, and Qihai for 30 min qd starting on the first day after HSCT was performed until the 14th day after transplantation, while treated conventionally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
highest pain score in HC patients within 100 days of transplantation
Time Frame: 100 days
highest pain score in HC patients within 100 days of transplantation
100 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute graft-versus-host disease
Time Frame: 100 days
100 days
Weighted Pain Score (WPS) in HC within 100 days post-transplant
Time Frame: 100 days

Weighted Pain Score (WPS) is a method used to assess the overall pain burden by considering both the intensity and the duration of pain. Steps to Calculate WPS:

Record Pain Intensity : Measure the patient's pain at various time points during the study or treatment.

Determine Time Intervals : Record the duration for which the pain was experienced at each time point.

Assign Weights : Weights are typically assigned based on the clinical significance of the time period. For example, if a patient experiences severe pain for a prolonged period, that period would have a higher weight.

Calculate the WPS: Multiply the pain intensity by the duration and the weight for each time period, and sum all these values to get the total WPS.
100 days
incidence of HC within 100 days post-transplant
Time Frame: 100 days
100 days
Granulocyte implantation rate
Time Frame: 100 days
100 days
Platelet implantation rate
Time Frame: 100 days
100 days
Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation
Time Frame: 100 days
100 days
Infection
Time Frame: 100 days
100 days
No relapse mortality, NRM
Time Frame: 100 days
100 days

Collaborators and Investigators

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

Sponsor

Yi Zhang

Collaborators

First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Zhengzhou University
The First People's Hospital of Yunnan

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)

March 21, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

December 21, 2023

First Submitted That Met QC Criteria

January 7, 2024

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT230700

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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