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

NCT07128953 | Enrolling By Invitation Early Phase 1 DMC

• 2 other identifiers: 2024AH-97-012023AH050848
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anal Fistula

Keywords

Anal fistula

Outcome Measures

Primary Outcomes (1)

• 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).

  From postoperative day 1 until wound healing is achieved (assessed daily during hospitalization and weekly after discharge, up to 8 weeks)

Study Arms (2)

Study Group

EXPERIMENTAL

ZQS

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

control Group

PLACEBO COMPARATOR

Control

Other: Equal-volume placebo inhalation rinse

Interventions

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

Study Group

Equal-volume placebo inhalation rinse OTHER

Equal-volume placebo inhalation rinse

control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine: lead

Study Sites (1)

Anhui university of Chinese Medicine

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Rectal Fistula

Interventions

Fumigation

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Anhui University of Chinese Medicine

Model Details: 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.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 19, 2025
• Study Start: August 1, 2025
• Primary Completion: August 2, 2025
• Study Completion: February 1, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)