Study on the Mechanism of Zuoqing San Promoting Postoperative Wound Healing of Anal Fistula by Inhibiting ROS-dependent NETosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula, Equal-volume placebo inhalation rinse.
- Who it may be relevant to
- Registry conditions: Anal Fistula. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The First Affiliated Hospital of Anhui University of Chinese Medicine
Overview
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.
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.
Interventions
- Drug 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. - Other Equal-volume placebo inhalation rinse
Equal-volume placebo inhalation rinse
Primary outcome measures
- 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)]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Anhui university of Chinese Medicine — Hefei
Identifiers
NCT: NCT07128953 · 2024AH-97-01 · 2023AH050848