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

NCT07128953 — Early Phase 1, Enrolling by invitation, 60 participants, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine

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The First Affiliated Hospital of Anhui University of Chinese Medicine

Registry	NCT07128953, acronym ZQS
Status	Enrolling by invitation
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	60 (Estimated)
Sponsor	The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine (Other)
Conditions	Anal Fistula
Interventions	Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula, Equal-volume placebo inhalation rinse (Drug, other)
Dates	start 2025-08-01, primary completion 2025-08-02, completion 2026-02-01 (estimated), first posted 2025-08-19, last updated 2025-08-19
Locations	1 site in China

-Summary

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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+Detailed 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.

+Arms and interventions

Arm	Type	Interventions	Description
Study Group	Experimental	Drug: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula	ZQS
control Group	Placebo comparator	Other: Equal-volume placebo inhalation rinse	Control

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

+Outcome measures

Primary outcomes

Wound healing time [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).

+Eligibility

Sex: All, ages: 18 Years to any

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:

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

+Locations (1)

Facility	City	Country	Status
Anhui university of Chinese Medicine	Hefei, Anhui	China