An Early Phase 1 interventional study of Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula and Equal-volume placebo inhalation rinse in Anal Fistula, sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine · Early Phase 1, Interventional, and Treatment
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.
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.
169 studies on the registry are indexed under Rectal Fistula; 45 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 115 interventional studies indexed under Rectal Fistula.
Browse Rectal Fistula studies →The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ZQS
Drug: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula
Control
Other: Equal-volume placebo inhalation rinse
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
Wound healing time
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).
Time frame: From postoperative day 1 until wound healing is achieved (assessed daily during hospitalization and weekly after discharge, up to 8 weeks)
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The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine