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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
266
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.
The control group received conventional symptomatic treatment.
Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou
Zhengzhou, Henan, China
RECRUITINGYi Zhang
Wuhan, Hubei, China
RECRUITINGHematology Department, The First People's Hospital of Yunnan
Kunming, Yunnan, China
RECRUITINGBone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGhighest 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
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
incidence of HC within 100 days post-transplant
Time frame: 100 days
Granulocyte implantation rate
Time frame: 100 days
Platelet implantation rate
Time frame: 100 days
Incidence of acute graft-versus-host disease
Time frame: 100 days
Cytomegalovirus (CMV)/Epstein-Barr virus (EBV) reactivation
Time frame: 100 days
Infection
Time frame: 100 days
No relapse mortality, NRM
Time frame: 100 days
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