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Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

ConditionsMoxibustionHematopoietic Stem Cell TransplantationHemorrhagic CystitisPrevention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorYi Zhang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Moxibustion

    Other intervention

    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 intervention

    The control group received conventional symptomatic treatment.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: MoxibustionExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

highest pain score in HC patients within 100 days of transplantation

highest pain score in HC patients within 100 days of transplantation

Time frame
100 days

Secondary outcomes

1

Weighted Pain Score (WPS) in HC within 100 days post-transplant

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.

Time frame
100 days
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Zhang

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Sponsor institution

The First People's Hospital of Yunnan

Collaborator

The First Affiliated Hospital of Zhengzhou University

Collaborator

First Affiliated Hospital of Zhejiang University

Collaborator

Source ClinicalTrials.gov
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