The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Phase
Phase EARLY_PHASE1
Started
2025-08-01
Last updated
2025-08-19
Condition(s) studied
Anal Fistula
Investigational drug(s) / intervention(s)
Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistulaEqual-volume placebo inhalation rinse
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;
Primary outcome measure(s)
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).
Trial sites (1)
Facility
City
Region
Status
Anhui university of Chinese Medicine
Hefei
Anhui
More The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.