Acupoint Application With Herbal Fumigation and Wash for Preventing Diarrhea-induced Perianal Infection in Allo-HSCT Patients

NCT06912347 | Enrolling By Invitation DMC

• 1 other identifier: 2025125
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

• Number of participants who suffered from different diarrhea severity

  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)

  From the beginning of pretreatment to 30 days after transplantation

• Number of participants who suffered from perianal infection

  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

  From the beginning of pretreatment to 30 days after transplantation

Secondary Outcomes (3)

• Number of participants who suffered from different hemorrhoids Grade

  From the beginning of pretreatment to 30 days after transplantation

• Number of participants who suffered from acute intestinal graft-versus-host disease

  From the beginning of pretreatment to 100 days after transplantation

• Number of participants who suffered from non-recurrent death

  From the beginning of pretreatment to 100 days after transplantation

Study Arms (2)

Acupoint Application Combined With Herbal Fumigation and Wash Group

EXPERIMENTAL

Starting 24 hours before pre-treatment, the participants 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.

Other: Intervention Group

Povidone-iodine warm water fumigation Group

ACTIVE COMPARATOR

Starting 24 hours before pre-treatment, the participants will receive povidone-iodine warm water fumigation of the perianal area twice daily (morning and afternoon), with each session lasting 15 minutes.

Other: control group

Interventions

Intervention Group OTHER

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.

Acupoint Application Combined With Herbal Fumigation and Wash Group

control group OTHER

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.

Povidone-iodine warm water fumigation Group

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin hospital

Shanghai, Shanghai Municipality, 200020, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: March 18, 2025
• Primary Completion: March 18, 2026
• Study Completion: March 30, 2026
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD Sharing Time Frame: Starting 6 months after publication, available for 5 years.
• Access Criteria: De-identified IPD will be shared with qualified researchers who provide a methodologically sound proposal. Data requests should include: Specific analysis objectives Statistical methods plan Ethics approval proof Approved requestors will gain access to: Anonymized participant-level data Study protocol/SAP Analytical codebook Access process: Submit proposal to \[qly02Q05@rjh.com.cn\] Institutional review (4-week turn around) Data transfer via encrypted platform after DUA execution

Locations

CN (1)