Moxibustion for the Prevention of Hemorrhagic Cystitis After Allo-HSCT

Yi Zhang

Status: Enrolling

Conditions: Prevention; Hemorrhagic Cystitis; Moxibustion; Hematopoietic Stem Cell Transplantation

Treatments: Other: Symptomatic treatment; Other: Moxibustion

Study type: Interventional

Funder types: Other

Identifiers

NCT06198517

UHCT230700

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients are fully aware of the study, participate voluntarily and sign the informed consent form (ICF);
2. Age: 14-60 years;
3. 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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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266 participants in 2 patient groups

Moxibustion

Experimental group

Treatment:

Other: Moxibustion

Control

Active Comparator group

Treatment:

Other: Symptomatic treatment