Actively Recruiting

Phase Not Applicable
Age: 14Years - 60Years
All Genders
ID06198517

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

Led by Yi Zhang · Updated on 2026-03-12

266

Participants Needed

4

Research Sites

13 weeks

Total Duration

On this page

Sponsors

Y

Yi Zhang

Lead Sponsor

T

The First People's Hospital of Yunnan

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of moxibustion to prevent hemorrhagic cystitis (HC) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) for blood diseases. This multicenter, randomized controlled study plans to enroll 266 patients aged 14 to 60 years with pernicious blood diseases or severe aplastic anemia receiving allo-HSCT. The goal is to assess whether moxibustion can reduce the incidence and severity of HC after transplantation. Participants are randomly divided into two groups. The experimental group receives moxibustion treatment applied to specific points (Zhongji, Guanyuan, and Qihai) for 30 minutes daily starting the first day after HSCT until day 14 post-transplant. The control group receives conventional symptomatic treatment. Urine tests for routine analysis and viruses are collected at admission, day 1, day 14, symptom onset, and remission of HC. Routine urine tests continue every 7 days for 100 days. During the study, researchers monitor HC symptoms daily in affected patients, including pain and severity scores, medication use, and traditional Chinese medicine evidence. Outcomes include highest pain score within 100 days post-transplant, incidence of HC, blood cell implantation rates, graft-versus-host disease, viral reactivation, infections, and mortality. Participants are followed for 100 days to evaluate these outcomes and treatment effects.

CONDITIONS

Brief Title

Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

Who Can Participate

Age: 14Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients are fully aware of the study, participate voluntarily and sign the informed consent form
  • Age between 14 and 60 years
  • Patients with pernicious blood diseases undergoing allo-HSCT using the MAC protocol or patients with severe aplastic anemia undergoing allo-HSCT
Not Eligible

You will not qualify if you...

  • Refusal to participate in this clinical study
  • Broken or sensitive skin at the moxibustion treatment sites
  • Patients who received reduced-intensity conditioning (RIC) before allo-HSCT

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 15 days

Participants receive moxibustion once daily for 30 minutes starting on the first day after allogeneic hematopoietic stem cell transplantation (HSCT) until the 14th day after transplantation, or receive conventional symptomatic treatment.

Daily visits for up to 15 days

Follow-up

Duration - Up to 100 days

Participants are monitored for outcomes including pain scores, incidence of hemorrhagic cystitis, graft implantation rates, graft-versus-host disease, viral reactivation, infection, and mortality for up to 100 days after transplantation.

Regular follow-up visits during the 100 days post-transplant

Trial Site Locations

Total: 4 locations

1

Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Zhengzhou, Henan, China, 450002

Actively Recruiting

2

Yi Zhang

Wuhan, Hubei, China, 430000

Actively Recruiting

3

Hematology Department, The First People's Hospital of Yunnan

Kunming, Yunnan, China, 650032

Actively Recruiting

4

Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

Hangzhou, Zhejiang, China, 311121

Not Yet Recruiting

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Research Team

Y

Yi Zhang, Dr

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Bacterial bloodstream infections in pediatric allogeneic hematopoietic stem cell recipients before and after implementation of a central line-associated bloodstream infection protocol: A single-center experience.

Alicia K Chang, Marc D Foca, Zhezhen Jin...

https://pubmed.ncbi.nlm.nih.gov/27378008

Outpatient haploidentical hematopoietic stem cell transplant using post-transplant cyclophosphamide and incidence of hemorrhagic cystitis.

Cesar Homero Gutiérrez-Aguirre, Alejandra Celina Esparza-Sandoval, Alain Palomares-Leal...

https://pubmed.ncbi.nlm.nih.gov/33814347

Full myeloablative conditioning and an unrelated HLA mismatched donor increase the risk for BK virus-positive hemorrhagic cystitis in allogeneic hematopoetic stem cell transplanted patients.

Tina Dalianis, Per Ljungman

https://pubmed.ncbi.nlm.nih.gov/21498717

A new regimen of MESNA (2-mercaptoethanesulfonate) effectively prevents cyclophosphamide-induced hemorrhagic cystitis in bone marrow transplant recipients.

N H Khojasteh, M Zakerinia, M Ramzi...

https://pubmed.ncbi.nlm.nih.gov/10812128

Hemorrhagic Cystitis after Haploidentical Transplantation with Post-Transplantation Cyclophosphamide: Protective Effect of MESNA Continuous Infusion.

Marcos Arango, Doris Cardona

https://pubmed.ncbi.nlm.nih.gov/32417488

Haemorrhagic cystitis, preventive and treatment interventions in patients undergoing haematopoietic stem cell transplantation: A scoping review.

Chiara Visintini, Margherita Venturini, Alvisa Palese

https://pubmed.ncbi.nlm.nih.gov/31446264