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Tongyangxiao Lotion for Postoperative Wound Healing After Anal Fistula Surgery

NCT07562672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2026-05-01

No results posted yet for this study

Summary

This study tests whether a traditional Chinese herbal bath called Tongyangxiao (TYX) lotion helps surgical wounds heal faster in patients who have had anal fistula surgery. Anal fistulas are abnormal tunnels near the anus that often require surgery, but the wound is usually left open and heals slowly. The study compares TYX lotion with a standard antiseptic bath (potassium permanganate). Patients use one of the two baths once daily for 14 days after surgery. The main goal is to see how long it takes for the wound to close completely. The study also measures pain, wound size, inflammation, and proteins involved in healing. A total of 115 patients took part, and laboratory experiments with human skin cells were also performed to understand how TYX works.

Conditions

  • Postoperative Wound Healing in Anal Fistula Surgery

Interventions

OTHER

Tongyangxiao (TYX) group

Patients receive a 15-minute sitz bath once daily with 1500 mL of Tongyangxiao decoction (40°C) from postoperative day 2 for 14 consecutive days. The decoction contains ten herbs: Huangbai (Phellodendron chinense), Kushen (Sophora flavescens), Danggui (Angelica sinensis), Cangzhu (Atractylodes lancea), Qinjiao (Gentiana macrophylla), Xixin (Asarum sieboldii), Fangfeng (Saposhnikovia divaricata), Chuanjiao (Zanthoxylum bungeanum), Mingfan (Alumen), and Mangxiao (Natrii Sulfas).

OTHER

Potassium permanganate (PP) group

atients receive a 15-minute sitz bath once daily with 1500 mL of 1:5000 potassium permanganate solution (40°C) from postoperative day 2 for 14 consecutive days.

Sponsors & Collaborators

  • Yongkang An

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

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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 NCT07562672 on ClinicalTrials.gov