Perianal infection
Conditions
Interventions
Exposure group:In addition to standard chemotherapy and basic care, patients are combined with receiving a prescribed Chinese herbal external therapy comprehensive treatment plan.
Non-exposure group:Only basic care during the routine chemotherapy period in hematology is accepted, and the Chinese herbal external treatment measures as specified in this protocol shall not be admin
Sponsors
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Patients are aged between 18 and 65 years (inclusive), with no restriction on gender; (2) Patients who meet the diagnostic criteria for acute myeloid leukemia according to Western medicine and are planned to receive a standard chemotherapy regimen; (3) Patients who have signed the informed consent form and voluntarily participate in this clinical study.
Exclusion criteria
Exclusion criteria: (1) Confirmed as acute promyelocytic leukemia (APL/M3 type); (2) Patients with leukemia who have undergone allogeneic hematopoietic stem cell transplantation or are currently undergoing chemotherapy; (3) Patients with other major illnesses (e.g., other malignant tumors, immunodeficiency diseases) or with severe dysfunction of major organs such as the heart, lungs, liver, or kidneys; (4) Patients with gastrointestinal infection, perianal infection, or antibiotic use within the past two weeks prior to enrollment; (5) Patients with a previous diagnosis of inflammatory bowel disease (IBD) or irritable bowel syndrome (IBS); (6) Patients with a Traditional Chinese Medicine (TCM) diagnosis of severe heat-toxicity or yin deficiency with hyperactivity of fire, and deemed unsuitable for the use of warm or hot TCM external therapies by the physician; (7) Patients with mental disorders or unable to provide informed consent; (8) Pregnant or breastfeeding women; (9) Patients with an allergy to the investigational drug or with physical conditions unsuitable for sitz baths; (10) Patients who have participated in other clinical trials within the past 4 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perianal infection incidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of diarrhea;Grading of Diarrhea Severity;First occurrence of perianal infection or diarrhea (Time in days);Immune-related indicators (complement, immunoglobulins, cytokines);Microbiological Testing;Stool pH;Traditional Chinese Medicine (TCM) Syndromes Information Collection Form; | — |
Countries
China
Contacts
Public ContactWang Zhenyi
Shanghai University of Traditional Chinese Medicine Affiliated Yueyang Integrated Chinese and Western Medicine Hospital
Outcome results
None listed