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

The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Status and phase

Invitation-only

Early Phase 1

Conditions

Anal Fistula

Treatments

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

Other: Equal-volume placebo inhalation rinse

Study type

Interventional

Funder types

Other

Identifiers

NCT07128953

2024AH-97-01

2023AH050848 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;