Ancient heat therapy tested for Life-Threatening transplant complication
NCT ID NCT07572669
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether moxibustion, a traditional Chinese medicine technique that involves burning dried mugwort near the skin, can help people with a severe complication of stem cell transplants called graft-versus-host disease (GVHD) that does not respond to steroids. The trial will enroll 42 patients who have gut symptoms like belly pain and diarrhea. All will receive standard second-line drugs, and some will also get moxibustion once or twice daily for 28 days. The main goal is to see if the combination improves response rates by day 28.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- moxibustion (a traditional Chinese medicine procedure involving burning dried mugwort near the skin at specific acupoints)
- What this could lead to
- If it works, this could offer a safe, non-drug add-on therapy to help control severe gut symptoms in patients who don't respond to steroids after a stem cell transplant.
- What could go wrong
- This is a small, early-phase (Phase 2) trial with only 42 participants, so results may not apply broadly. Moxibustion is an unproven complementary therapy, and any benefit over standard care alone is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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14 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants must meet all of the following criteria: Age 14 to 65 years, male or female. Underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT). Diagnosis of acute graft-versus-host disease (aGVHD) according to standard criteria, with gastrointestinal involvement (e.g., abdominal pain and diarrhea), and classified as grade II-IV. Steroid-refractory or steroid-dependent aGVHD, defined as: Disease progression within 3 days of systemic corticosteroid treatment, or No response within 7 days, or Failure to achieve complete response after 28 days of immunosuppressive therapy, or Recurrence or worsening during steroid tapering. Absolute neutrophil count ≥ 0.5 × 10⁹/L for at least 3 consecutive days. Traditional Chinese medicine (TCM) syndrome differentiation consistent with spleen-kidney yang deficiency. Female participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study. Male participants must agree to use effective contraception during the study. Ability to understand and willingness to sign a written informed consent form. Willingness and ability to comply with study procedures and follow-up. Exclusion Criteria: * Participants meeting any of the following criteria will be excluded: Prior treatment with ≥1 systemic therapy for aGVHD other than corticosteroids. Diagnosis of GVHD overlap syndrome according to NIH criteria. History of splenectomy after transplantation. Evidence of relapse of the underlying disease or receipt of anti-relapse therapy after transplantation. Unresolved toxicities or complications from prior transplantation (excluding GVHD). Prior moxibustion therapy after transplantation. Uncontrolled active infection. Known human immunodeficiency virus (HIV) infection. Active hepatitis B or C infection requiring treatment, or risk of HBV reactivation. Receipt of other investigational therapy within 21 days prior to enrollment (or within 5 half-lives, whichever is longer). Renal dysfunction: serum creatinine ≥ 2.0 mg/dL or creatinine clearance \< 40 mL/min. Hepatic dysfunction unrelated to GVHD, including cholestatic disease or unresolved hepatic veno-occlusive disease. Severe cardiovascular disease, including unstable angina, myocardial infarction within 6 months, NYHA class III-IV heart failure, or circulatory failure requiring vasoactive support. Severe respiratory disease requiring mechanical ventilation or ≥50% oxygen support. Use of high-dose corticosteroids (≥1 mg/kg/day methylprednisolone or equivalent) for non-GVHD indications within 7 days prior to enrollment. Pregnant or breastfeeding women. Severe skin damage or known allergy/intolerance to study-related procedures. Any other condition that, in the investigator's judgment, would interfere with study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Platelet-Boosting drug speed recovery after stem cell transplant?
- Can a detailed health check predict who thrives after a stem cell transplant?
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug stop the Body's attack after stem cell transplants?
- Could a simple timing change make stem cell transplants safer?
- Can a Life-Saving transplant leave hidden scars on a Child's mind?