MedTrace Logo

Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy

NCT06663527 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-12

No results posted yet for this study

Summary

Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.

Conditions

  • Fistula in Ano

Interventions

COMBINATION_PRODUCT

Fumigating-washing Therapy With CPD

All patients underwent anal fistulectomy based on the Parks classification. For postoperative infection prophylaxis, cefuroxime was used at a dosage of 2g per dose, twice daily. Commencing the day following surgery, a fumigating-washing therapy was conducted once daily either after defecation or two hours prior to intravenous infusion. In the study group, a medical solution used for fumigating-washing therapy was prepared by blending 200 ml of CPD with 2 liters of water at 40 °C. This medicinal solution was then transferred into the reservoir of an ultrasonic atomizing fumigating-washing device (Model:TM50-C, Xuzhou Tianma Medical Equipment Factory, China) that was classified by the FDA as Class II (special controls).

COMBINATION_PRODUCT

fumigating-washing therapy with a placebo

fumigating-washing therapy with a placebo

Sponsors & Collaborators

  • The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-26
Primary Completion
2025-02-01
Completion
2025-02-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06663527 on ClinicalTrials.gov