The First Affiliated Hospital of Anhui University of Chinese Medicine
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Wound healing time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Study Group
ZQS
干预措施: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula (Drug)
control Group
Control
干预措施: Equal-volume placebo inhalation rinse (Other)
结局指标
主要结局
Wound healing time
时间窗: 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).
次要结局
未报告次要终点
研究者
Heng Deng
The First Affiliated Hospital of Anhui University of Chinese Medicine
The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine