Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT

NCT ID: NCT06241274

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-15

Study Completion Date

2025-12-31

Brief Summary

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This study was a prospective, multicenter, single-arm clinical study planned to enroll 60 patients who developed hemorrhagic cystitis after sexually allogeneic hematopoietic stem cell transplantation Patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation were given symptomatic supportive treatment combined with moxibustion covering Shenque, Zhongguo, Guanyuan, and Qihai for 30 minutes every day for 14 days and urine routine was collected every day for 14 days to assess the severity of hemorrhagic cystitis and pain scores to evaluate the effectiveness of moxibustion in treating hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation.

Detailed Description

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Conditions

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Moxibustion Hematopoietic Stem Cell Transplantation Hemorrhagic Cystitis Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Moxibustion

Subjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Group Type EXPERIMENTAL

Moxibustion

Intervention Type OTHER

Subjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Symptomatic supportive treatment

Intervention Type OTHER

Symptomatic supportive treatment.

Interventions

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Moxibustion

Subjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.

Intervention Type OTHER

Symptomatic supportive treatment

Symptomatic supportive treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
2. Age: 18-55 years old;
3. patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;

Exclusion Criteria

1. refusal to participate in this clinical study;
2. broken or sensitized skin corresponding to the moxibustion site;
3. allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Yi Zhang

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yi Zhang

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Zhang

Role: CONTACT

+86 15639790587

Facility Contacts

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Yi Zhang

Role: primary

References

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Chang AK, Foca MD, Jin Z, Vasudev R, Laird M, Schwartz S, Qureshi M, Kolb M, Levinson A, Bhatia M, Kung A, Garvin J, George D, Della-Latta P, Whittier S, Saiman L, Satwani P. Bacterial bloodstream infections in pediatric allogeneic hematopoietic stem cell recipients before and after implementation of a central line-associated bloodstream infection protocol: A single-center experience. Am J Infect Control. 2016 Dec 1;44(12):1650-1655. doi: 10.1016/j.ajic.2016.04.229. Epub 2016 Jul 1.

Reference Type BACKGROUND
PMID: 27378008 (View on PubMed)

Mackall C, Fry T, Gress R, Peggs K, Storek J, Toubert A; Center for International Blood and Marrow Transplant Research (CIBMTR); National Marrow Donor Program (NMDP); European Blood and Marrow Transplant Group (EBMT); American Society of Blood and Marrow Transplantation (ASBMT); Canadian Blood and Marrow Transplant Group (CBMTG); Infectious Disease Society of America (IDSA); Society for Healthcare Epidemiology of America (SHEA); Association of Medical Microbiology and Infectious Diseases Canada (AMMI); Centers for Disease Control and Prevention (CDC). Background to hematopoietic cell transplantation, including post transplant immune recovery. Bone Marrow Transplant. 2009 Oct;44(8):457-62. doi: 10.1038/bmt.2009.255. No abstract available.

Reference Type BACKGROUND
PMID: 19861978 (View on PubMed)

Gutierrez-Aguirre CH, Esparza-Sandoval AC, Palomares-Leal A, Jaime-Perez JC, Gomez-Almaguer D, Cantu-Rodriguez OG. Outpatient haploidentical hematopoietic stem cell transplant using post-transplant cyclophosphamide and incidence of hemorrhagic cystitis. Hematol Transfus Cell Ther. 2022 Apr-Jun;44(2):163-168. doi: 10.1016/j.htct.2020.09.149. Epub 2020 Dec 4.

Reference Type BACKGROUND
PMID: 33814347 (View on PubMed)

Dalianis T, Ljungman P. Full myeloablative conditioning and an unrelated HLA mismatched donor increase the risk for BK virus-positive hemorrhagic cystitis in allogeneic hematopoetic stem cell transplanted patients. Anticancer Res. 2011 Mar;31(3):939-44.

Reference Type BACKGROUND
PMID: 21498717 (View on PubMed)

Hassan Z, Remberger M, Svenberg P, Elbander M, Omazic B, Mattsson J, Conrad R, Svahn BM, Ahlgren A, Sairafi D, Aschan J, Le Blanc K, Barkholt L, Ringden O. Hemorrhagic cystitis: a retrospective single-center survey. Clin Transplant. 2007 Sep-Oct;21(5):659-67. doi: 10.1111/j.1399-0012.2007.00705.x.

Reference Type BACKGROUND
PMID: 17845642 (View on PubMed)

Arango M, Cardona D. Hemorrhagic Cystitis after Haploidentical Transplantation with Post-Transplantation Cyclophosphamide: Protective Effect of MESNA Continuous Infusion. Biol Blood Marrow Transplant. 2020 Aug;26(8):1492-1496. doi: 10.1016/j.bbmt.2020.04.028. Epub 2020 May 15.

Reference Type BACKGROUND
PMID: 32417488 (View on PubMed)

Tang B, Zhang J, Yang Z, Lu Y, Xu Q, Chen X, Lin J. Moxibustion for Diarrhea-Predominant Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2016;2016:5105108. doi: 10.1155/2016/5105108. Epub 2016 May 16.

Reference Type BACKGROUND
PMID: 27293460 (View on PubMed)

Sun ZR, Wang CB, Yin HN, Luan YX, Liu YX, Gong RQ, Gong N, Wang BL, Miao CX. [Network Meta-analysis of acupuncture and moxibustion for allergic rhinitis]. Zhongguo Zhen Jiu. 2021 Nov 12;41(11):1295-302. doi: 10.13703/j.0255-2930.20200916-0002. Chinese.

Reference Type BACKGROUND
PMID: 34762387 (View on PubMed)

Li X, Li ZM, Tan JY, Wang T, Chen JX, Chen X, Yang L, Suen LKP. Moxibustion for post-stroke urinary incontinence in adults: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Clin Pract. 2021 Feb;42:101294. doi: 10.1016/j.ctcp.2020.101294. Epub 2020 Dec 24.

Reference Type BACKGROUND
PMID: 33360387 (View on PubMed)

Other Identifiers

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UHCT230698

Identifier Type: -

Identifier Source: org_study_id

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