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NCT Number: NCT06198517

Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

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.

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Key information

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
  • Age: 14-60 years;
  • 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

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

Treatment and study plan

moxibustion

Other

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.

Symptomatic treatment

Other

The control group received conventional symptomatic treatment.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. incidence of HC within 100 days post-transplant

    Time frame: 100 days

  3. Granulocyte implantation rate

    Time frame: 100 days

  4. Platelet implantation rate

    Time frame: 100 days

  5. Incidence of acute graft-versus-host disease

    Time frame: 100 days

  6. Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation

    Time frame: 100 days

  7. Infection

    Time frame: 100 days

  8. No relapse mortality, NRM

    Time frame: 100 days

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Zhang, Dr

CONTACT

[email protected]

+86 15639790587

Sponsors and collaborators

Lead sponsor

Yi Zhang

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2024
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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