Intervention Group: Starting 24 hours before pre-treatment, you will receive herbal fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 5 minutes. Additionally, starting 30 minutes after each meal, acupoint application will be performed on five acupoints: Shenque (CV8), Tianshu (ST25), and bilateral Zusanli (ST36). The application will last 4 hours per day.
control group: Starting 24 hours before pre-treatment, you will receive povidone-iodine warm water fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 15 minutes.
Study summary
The goal of this clinical trial is to evaluate whether the combination of herbal fumigation and acupoint application can effectively prevent diarrhea in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).The main questions it aims to answer are:
Does the combination of herbal fumigation and acupoint application reduce the incidence of diarrhea in allo-HSCT patients? Does this intervention improve patients' quality of life and reduce the risk of perianal infections? Researchers will compare the intervention group (herbal fumigation + acupoint application) to the control group (povidone-iodine warm water fumigation) to determine the effectiveness of the TCM-based approach in preventing diarrhea and related complications.
Participants will:
Receive either herbal fumigation and acupoint application or povidone-iodine warm water fumigation twice daily, starting from 24h before transplant conditioning until 30 days post-transplantation (Day +30).
Undergo daily monitoring of perianal and local skin conditions, as well as diarrhea symptoms, by trained professionals.
This study aims to provide evidence for a non-invasive, low-risk TCM approach to improving outcomes for allo-HSCT patients.
Eligibility
Sex
ALL
Min age
14 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* First-time recipient of allogeneic hematopoietic stem cell transplantation.
* Age between 14 and 70 years old, regardless of gender.
* Primary disease type: Hematologic malignancies or aplastic anemia, with no restrictions on disease stage or remission status.
* Transplant type: Matched sibling donor, haploidentical related donor, or unrelated donor.
* Transplant conditioning regimen: Myeloablative, reduced-intensity, or non-myeloablative.
* Informed consent and voluntary participation in this clinical study.
Exclusion Criteria:
* Presence of intestinal infection within 2 weeks prior to enrollment.
* Previous diagnosis of inflammatory bowel disease or irritable bowel syndrome.
* Pathologically or radiologically confirmed involvement of the primary disease in the intestines.
* ECOG performance status ≥ 2, or presence of organ failure, rendering the patient unable to tolerate allogeneic hematopoietic stem cell transplantation.
* Allergy to the trial medications or physical conditions unsuitable for sitz baths.
* Individuals with mental disorders or those unable to provide informed consent.
* Poor compliance, such as failure to implement the intervention measures for 3 consecutive days.
* HIV-infected individuals, or those with a history of drug abuse or chronic alcoholism that may affect the evaluation of trial results.
Primary outcome measure(s)
Number of participants who suffered from different diarrhea severity — From the beginning of pretreatment to 30 days after transplantation The severity of diarrhea was assessed using the ECOG version of the Common Toxicity Criteria (CTC) grading system:
Grade 0: No diarrhea Grade 1: 2-3 loose stools per day above baseline Grade 2: 4-6 loose stools per day above baseline Grade 3: 7-9 loose stools per day above baseline Grade 4: ≥10 loose stools per day above baseline with dehydration or requiring parenteral nutrition (Severe diarrhea was defined as ≥Grade 3)
Number of participants who suffered from perianal infection — From the beginning of pretreatment to 30 days after transplantation Perianal Infection Grading adapted from WHO guidelines for perianal infection assessment:
Grade 0 (No infection): Intact perianal skin/mucosa, dry and clean, asymptomatic Grade 1: Induration and/or mucosal erythema, painful defecation without bleeding Grade 2: Perianal erythema with swelling/tenderness, OR skin fissures \<0.5cm Grade 3: Abscess formation OR fissures ≥0.5cm with surrounding inflammation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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