RecruitingNot ApplicableNCT06198517

Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

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


Sponsor

Yi Zhang

Enrollment

266 participants

Start Date

Mar 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 14 YearsMax Age: 60 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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;

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Interventions

OTHERMoxibustion

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.

OTHERSymptomatic treatment

The control group received conventional symptomatic treatment.


Locations(4)

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

Zhengzhou, Henan, China

Yi Zhang

Wuhan, Hubei, China

Hematology Department, The First People's Hospital of Yunnan

Kunming, Yunnan, China

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

Hangzhou, Zhejiang, China

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NCT06198517


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