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Enrolling by Invitation

NCT Number: NCT07128953

Study on the Mechanism of Zuoqing San Promoting Postoperative Wound Healing of Anal Fistula by Inhibiting ROS-dependent NETosis

This study adopted a randomized, double-blind, placebo-controlled clinical trial design to evaluate the efficacy and safety of Zuoqing San fumigation and washing on the wound healing after anal fistula surgery.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Anhui university of Chinese Medicine

Hefei, Anhui, 230000, China

About this study

A total of 60 patients who underwent anal fistula surgery at the Second Affiliated Hospital of Anhui University of Chinese Medicine from September 2024 to March 2025 were included. They were randomly divided into the experimental group (treated with Left Qing San fumigation and washing) and the control group (treated with placebo fumigation and washing) at a ratio of 1:1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recurrent swelling and pain, along with pus discharge around the anus;
  • Preoperative MRI or ultrasound confirmed the presence of the fistula;
  • Underwent incision of the anal fistula, with the postoperative wound diameter ranging from 2 to 4 cm.

Exclusion criteria

  • Inflammatory bowel disease (such as Crohn's disease) related anal fistula;
  • Complicated with severe dysfunction of heart, liver and kidney (ALT/AST > 2 times upper limit, Cr > 1.5 mg/dL);
  • Pregnant or lactating women;
  • Those who are known to be allergic to the components of Zuoqing San;

Treatment and study plan

Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula

Drug

Left Qing San Decoction (25g of Cai Yin + 30g of Eucommia + 25g of Sophora flavescens + 25g of Anemarrhena asphodeloides + 15g of Lithospermum erythrorhizon, prepared in the Pharmacy Department of Anhui University of Traditional Chinese Medicine), add 1000mL of water, boil, then steam and wash the wound surface. The temperature is 40 ± 2℃. Do it once a day, for 15 minutes each time, for 7 consecutive days.

Equal-volume placebo inhalation rinse

Other

Equal-volume placebo inhalation rinse

Primary outcomes

  1. Wound healing time

    Time frame: From postoperative day 1 until wound healing is achieved (assessed daily during hospitalization and weekly after discharge, up to 8 weeks)

    The number of days from the day after the operation until the wound surface is completely covered by epithelium (as observed by the naked eye, there is no exudation, and upon palpation, the scar is smooth).

Sponsors and collaborators

Lead sponsor

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Other

Registry information

Official study title

The First Affiliated Hospital of Anhui University of Chinese Medicine

Acronym: ZQS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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