Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation

Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation - Hangeshashinto for the prevention of oral mucositis in patients receiving with allogeneic hematopoietic stem cell transplantation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012275

Enrollment

Registered

2013-11-15

Start date

2013-11-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological malignancy

Interventions

Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) acute leukemia, adult T cell leukemia/lymphoma, myelodysplastic syndrome, multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's lymphoma. 2) Performance status : Eastern Cooperative Oncology Group (ECOG)<3 3) Patients must have adequate cardiac, hepatic, renal, and pulmonary functions.

Exclusion criteria

Exclusion criteria: 1) Patients seropositive for HIV or HBs. 2) Severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study. 3) Pregnant or breastfeeding women. 4) Patient has another progressive malignant disease. 5) Uncontrolled infections. 6) Acute Myocardial Infarction and heart failure within the last 12 months. 7) Liver cirrhosis. 8) BMI>=35. 9) Arrhythmias: CTCAE v4.0 Grade>=3. 10) Contraindication of Hangeshashinto. 11) Oral mucositis: CTCAE v3.0 Grade>=3. 12) Patients who, in the judgment of the investigator, would be inappropriate for entry into this study.

Design outcomes

Primary

Measure	Time frame
Incidence of CTCAE Grade3<=oral mucositis	—

Countries

Japan

Contacts

Public ContactKohei Okada

Hokkaido University Hospital Department of Hematology

okada@med.hokudai.ac.jp011-706-7214

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026