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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

EARLY_PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2026-02-01

Brief Summary

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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

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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.

Conditions

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Anal Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Inclusion criteria\*\*

1\. \*\*Western medical diagnostic criteria\*\* (refer to "Surgery for Anorectal Diseases" 2018 edition):

* History of recurrent swelling and pus discharge around the anus;
* Confirmed presence of fistula through preoperative MRI or ultrasound;
* Undergone incisional surgery for anal fistula, with postoperative wound diameter ranging from 2 to 4 cm.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Study Group

ZQS

Group Type EXPERIMENTAL

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

Intervention Type 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.

control Group

Control

Group Type PLACEBO_COMPARATOR

Equal-volume placebo inhalation rinse

Intervention Type OTHER

Equal-volume placebo inhalation rinse

Interventions

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

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.

Intervention Type DRUG

Equal-volume placebo inhalation rinse

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No