MoxibustionNCT06241274
Moxibustion in the Treatment of Hemorrhagic Cystitis After Allo-HSCT
A study testing Moxibustion and Symptomatic supportive treatment in people with Moxibustion and Hematopoietic Stem Cell Transplantation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Moxibustion, Hematopoietic Stem Cell Transplantation, Hemorrhagic Cystitis
- What is being tested?
- Moxibustion and Symptomatic supportive treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
- Age: 18-55 years old;
- patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;
Who cannot join
- refusal to participate in this clinical study;
- broken or sensitized skin corresponding to the moxibustion site;
- allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Moxibustion in the Treatment of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation
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.
- Being tested
- Moxibustion, Symptomatic supportive treatment
- Medical subject headings
- Cystitis, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxibustionOther
Subjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days.
Symptomatic supportive treatmentOther
Symptomatic supportive treatment.
| Study group | Role | What they receive |
|---|---|---|
| Moxibustion | Experimental | Subjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days. Receives: Other: Moxibustion; Other: Symptomatic supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Lower Urinary Tract Symptom Score
The Core Lower Urinary Tract Symptom Score consists of 10 questions. Frequent daytime urination---0 points:<7 times;1 point:8~9 times;2 points:10~14 times;3 points:> 14 times. Nocturia---0 points:0 times/night;1 point:1 time/night;2 points: 2~3 times/night;3 points:> 3 times/night. The other 8 problems were urgency, dysuria, hesitancy, thin urine line, urge incontinence, stress incontinence, bladder pain, and urethral pain, which were rated as 0, 1, 2, and 3 according to their frequency (never, rarely, sometimes, and often).
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start15 Aug 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MoxibustionStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241274
- Sponsor's protocol ID
- UHCT230698
- Status last verified
- Jul 2024
- First submitted
- 7 Jan 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27378008Mackall 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.
PubMed 19861978Gutierrez-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.
PubMed 33814347Dalianis 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.
PubMed 21498717Hassan 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.
PubMed 17845642Arango 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.
PubMed 32417488Tang 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.
PubMed 27293460Sun 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.
PubMed 34762387Li 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.
PubMed 33360387
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Moxibustion in the Treatment of Hemorrhagic Cystitis After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06241274
- Acronym / sponsor ID
- UHCT230698
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moxibustion | Experimental | Other: Moxibustion, Other: Symptomatic supportive treatmentSubjects received symptomatic supportive treatment combined with moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients were fully aware of the study, participated voluntarily, and signed the informed consent form;
- Age: 18-55 years old;
- patients with hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation;
Key exclusion criteria (3 listed)
- refusal to participate in this clinical study;
- broken or sensitized skin corresponding to the moxibustion site;
- allogeneic hematopoietic stem cell transplantationpatients pretreated with the Reduced-intensity conditioning.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxibustionSubjects received moxibustion covering Shenque, Zhonggong, Guanyuan, and Qihai for 30 minutes every day for 14 days. | Other | Moxibustion |
| Symptomatic supportive treatmentSymptomatic supportive treatment. | Other | Moxibustion |
Primary outcome
Core Lower Urinary Tract Symptom Score
Time frame: 14 days
The Core Lower Urinary Tract Symptom Score consists of 10 questions. Frequent daytime urination---0 points:<7 times;1 point:8~9 times;2 points:10~14 times;3 points:> 14 times. Nocturia---0 points:0 times/night;1 point:1 time/night;2 points: 2~3 times/night;3 points:> 3 times/night. The other 8 problems were urgency, dysuria, hesitancy, thin urine line, urge incontinence, stress incontinence, bladder pain, and urethral pain, which were rated as 0, 1, 2, and 3 according to their frequency (never, rarely, sometimes, and often).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Background: PubMed 27378008Chang 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.
- Background: PubMed 19861978Mackall 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.
- Background: PubMed 33814347Gutierrez-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.
- Background: PubMed 21498717Dalianis 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.
- Background: PubMed 17845642Hassan 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.
- Background: PubMed 32417488Arango 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.
- Background: PubMed 27293460Tang 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.
- Background: PubMed 34762387Sun 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.
- Background: PubMed 33360387Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moxibustion and Symptomatic supportive treatment in people with Moxibustion and Hematopoietic Stem Cell Transplantation, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Zhang (+86 15639790587, zy188603@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Lower Urinary Tract Symptom Score (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06241274, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.