Anal FistulaEarly Phase 1ZQSNCT07128953
Study on the Mechanism of Zuoqing San Promoting Postoperative Wound Healing of Anal Fistula by Inhibiting ROS-dependent NETosis
A Early Phase 1 study testing Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula in people with Anal Fistula, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Feb 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The First Affiliated Hospital of Anhui University of Chinese Medicine
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.
Read the 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.
- Conditions
- Anal Fistula
- Being tested
- Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula, Equal-volume placebo inhalation rinse
- Keywords
- Anal fistula
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistulaDrug
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 rinseOther
Equal-volume placebo inhalation rinse
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | ZQS Receives: Drug: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula |
| control Group | Placebo comparator | Control Receives: Other: Equal-volume placebo inhalation rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From postoperative day 1 until wound healing is achieved (assessed daily during hospitalization and weekly after discharge, up to 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Aug 2025
- Primary completion2 Aug 2025
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128953
- Sponsor's protocol ID
- 2024AH-97-01
- Other IDs
- 2023AH050848
- Acronym
- ZQS
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The First Affiliated Hospital of Anhui University of Chinese Medicine
- ClinicalTrials.gov ID
- NCT07128953
- Acronym / sponsor ID
- ZQS / 2024AH-97-01
- Conditions
- Anal Fistula
- Keywords
- Anal fistula
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Drug: Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistulaZQS |
| control Group | Placebo comparator | Other: Equal-volume placebo inhalation rinseControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistulaLeft 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. | Drug | Study Group |
| Equal-volume placebo inhalation rinseEqual-volume placebo inhalation rinse | Other | control Group |
Primary outcome
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Solution of Zuoqing San for fumigation and washing of the postoperative wound of anal fistula in people with Anal Fistula, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.