Tongyangxiao Lotion for Postoperative Wound Healing After Anal Fistula Surgery

NCT07562672 | Completed DMC

• 1 other identifier: YXLL2021010
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tongyangxiao Lotion; Anal fistula; Wound Healing; PI3K-Akt-mTOR signaling pathway; Traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• Wound healing time

  Number of days from surgery to complete wound closure (complete epithelialization without need for dressing).Time Frame

  From date of surgery until complete epithelialization, assessed daily up to 60 days

Secondary Outcomes (6)

• Wound area

  Postoperative days 5, 7, and 14

• Exudate score

  Postoperative days 5, 7, and 14

• Pain score (VAS)

  Postoperative days 5, 10, and 14

• Inflammatory cytokines (TNF-α, IL-6, IL-1β)

  Postoperative days 7 and 14

• PI3K-Akt-mTOR pathway proteins (p-PI3K, p-Akt, p-mTOR)

  Postoperative days 7 and 14

Study Arms (2)

Tongyangxiao (TYX) group

EXPERIMENTAL

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: Tongyangxiao (TYX) group; Other: Potassium permanganate (PP) group

Potassium permanganate (PP) group

ACTIVE COMPARATOR

Patients 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.

Other: Tongyangxiao (TYX) group; Other: Potassium permanganate (PP) group

Interventions

Tongyangxiao (TYX) group OTHER

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).

Potassium permanganate (PP) group; Tongyangxiao (TYX) group

Potassium permanganate (PP) group OTHER

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.

Also known as: Active Comparator

Potassium permanganate (PP) group; Tongyangxiao (TYX) group

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65 years
• Diagnosis of low simple anal fistula according to the Chinese expert consensus on diagnosis and treatment of anal fistula (2020 edition)
• Traditional Chinese medicine pattern of damp-heat downward infusion
• Underwent low anal fistulectomy
• No surgical contraindications

You may not qualify if:

• Complex or high anal fistula
• Inflammatory bowel disease, diabetes mellitus, or severe cardiac / liver / renal dysfunction
• Allergy to any component of Tongyangxiao lotion or potassium permanganate
• Pregnancy or lactation
• Participation in another clinical trial within 3 months

Sponsors & Collaborators

• Yongkang An: lead

Study Sites (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000,, China

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

Population Groups; Potassium Permanganate

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Manganese Compounds; Inorganic Chemicals; Potassium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 1, 2026
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)