Postoperative Wound Healing in Anal Fistula SurgeryNCT07562672
Tongyangxiao Lotion for Postoperative Wound Healing After Anal Fistula Surgery
A study testing Tongyangxiao (TYX) group and Potassium permanganate (PP) group in people with Postoperative Wound Healing in Anal Fistula Surgery, run by Yongkang An at 1 site in China.
Trial summary
This study tests whether a traditional Chinese herbal bath called Tongyangxiao (TYX) lotion helps surgical wounds heal faster in patients who have had anal fistula surgery. Anal fistulas are abnormal tunnels near the anus that often require surgery, but the wound is usually left open and heals slowly. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Wound Healing in Anal Fistula Surgery
- What is being tested?
- Tongyangxiao (TYX) group and Potassium permanganate (PP) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 65 years
- Diagnosis of low simple anal fistula according to the Chinese expert consensus on diagnosis and treatment of anal fistula (2020 edition)
- Traditional Chinese medicine pattern of damp-heat downward infusion
- Underwent low anal fistulectomy
- No surgical contraindications
Who cannot join
- Complex or high anal fistula
- Inflammatory bowel disease, diabetes mellitus, or severe cardiac / liver / renal dysfunction
- Allergy to any component of Tongyangxiao lotion or potassium permanganate
- Pregnancy or lactation
- Participation in another clinical trial within 3 months
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000,
About this study
Official title: Tongyangxiao Lotion Accelerates Postoperative Wound Healing in Anal Fistula Surgery by Activating the PI3K-Akt-mTOR Pathway
This study tests whether a traditional Chinese herbal bath called Tongyangxiao (TYX) lotion helps surgical wounds heal faster in patients who have had anal fistula surgery. Anal fistulas are abnormal tunnels near the anus that often require surgery, but the wound is usually left open and heals slowly. The study compares TYX lotion with a standard antiseptic bath (potassium permanganate). Patients use one of the two baths once daily for 14 days after surgery. The main goal is to see how long it takes for the wound to close completely. The study also measures pain, wound size, inflammation, and proteins involved in healing. A total of 115 patients took part, and laboratory experiments with human skin cells were also performed to understand how TYX works.
Read the detailed description
This prospective, single-blind, randomized controlled trial was conducted at two hospitals in China (The First Affiliated Hospital of Hebei University of Chinese Medicine and The First Affiliated Hospital of Henan University of Chinese Medicine) from June 2023 to June 2024. The study enrolled 115 patients aged 18-65 years with low simple anal fistula who underwent low anal fistulectomy. Patients were randomly assigned to either the Tongyangxiao (TYX) group (n=58) or the potassium permanganate (PP) group (n=57). Starting on postoperative day 2, the TYX group received a 15-minute sitz bath once daily with 1500 mL of TYX decoction (40°C) for 14 days. The TYX decoction contains ten herbs: Huangbai, Kushen, Danggui, Cangzhu, Qinjiao, Xixin, Fangfeng, Chuanjiao, Mingfan, and Mangxiao. The PP group received a 15-minute sitz bath with 1:5000 potassium permanganate solution (40°C) for the same duration.
The primary outcome was wound healing time (days from surgery to complete epithelialization). Secondary outcomes included wound area (measured by ImageJ at days 5,7,14), exudate score, pain by visual analog scale (VAS, days 5,10,14), serum and tissue levels of inflammatory cytokines (TNF-α, IL-6, IL-1β) by ELISA and immunohistochemistry, expression of PI3K-Akt-mTOR pathway proteins (p-PI3K, p-Akt, p-mTOR) by Western blot and immunohistochemistry, and collagen I/III expression by Western blot, qPCR, and immunohistochemistry. Safety was monitored by recording adverse events.
In parallel, network pharmacology predicted PI3K-Akt as a core pathway. An in vitro experiment using human fibroblast HFF-1 cells treated with TNF-α (50 ng/mL) was performed to model inflammation. Cells were treated with TYX lyophilized powder (0.1 or 0.5 mg/mL), the PI3K activator 740Y-P, or their combination. Cell migration was assessed by Transwell assay; pathway protein expression and collagen were measured by Western blot and immunofluorescence.
The study was approved by the Ethics Committee of Hebei University of Chinese Medicine (YXLL2021010) and the sub-center (2021HL-248-01). All patients gave written informed consent. No U.S. government funding or IND/IDE was involved.
Results demonstrate that TYX significantly shortened wound healing time, reduced pain and exudate, decreased inflammatory cytokines, and upregulated PI3K-Akt-mTOR phosphorylation and collagen deposition. In vitro, TYX reversed TNF-α-induced suppression of fibroblast migration and pathway activity. These findings support the clinical use of TYX lotion to accelerate postoperative wound healing in anal fistula surgery by activating the PI3K-Akt-mTOR signaling pathway.
- Being tested
- Tongyangxiao (TYX) group, Potassium permanganate (PP) group
- Keywords
- Tongyangxiao Lotion; Anal fistula; Wound Healing; PI3K-Akt-mTOR signaling pathway; Traditional Chinese medicine
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tongyangxiao (TYX) groupOther
Patients receive a 15-minute sitz bath once daily with 1500 mL of Tongyangxiao decoction (40°C) from postoperative day 2 for 14 consecutive days. The decoction contains ten herbs: Huangbai (Phellodendron chinense), Kushen (Sophora flavescens), Danggui (Angelica sinensis), Cangzhu (Atractylodes lancea), Qinjiao (Gentiana macrophylla), Xixin (Asarum sieboldii), Fangfeng (Saposhnikovia divaricata), Chuanjiao (Zanthoxylum bungeanum), Mingfan (Alumen), and Mangxiao (Natrii Sulfas).
Potassium permanganate (PP) groupOther
Also called Active Comparator
atients receive a 15-minute sitz bath once daily with 1500 mL of 1:5000 potassium permanganate solution (40°C) from postoperative day 2 for 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Tongyangxiao (TYX) group | Experimental | Patients receive a 15-minute sitz bath once daily with 1500 mL of Tongyangxiao decoction (40°C) from postoperative day 2 for 14 consecutive days. The decoction contains ten herbs: Huangbai (Phellodendron chinense), Kushen (Sophora flavescens), Danggui (Angelica sinensis), Cangzhu (Atractylodes lancea), Qinjiao (Gentiana macrophylla), Xixin (Asarum sieboldii), Fangfeng (Saposhnikovia divaricata), Chuanjiao (Zanthoxylum bungeanum), Mingfan (Alumen), and Mangxiao (Natrii Sulfas). Receives: Other: Tongyangxiao (TYX) group; Other: Potassium permanganate (PP) group |
| Potassium permanganate (PP) group | Active comparator | Patients receive a 15-minute sitz bath once daily with 1500 mL of 1:5000 potassium permanganate solution (40°C) from postoperative day 2 for 14 consecutive days. Receives: Other: Tongyangxiao (TYX) group; Other: Potassium permanganate (PP) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Number of days from surgery to complete wound closure (complete epithelialization without need for dressing).Time Frame
Measured: From date of surgery until complete epithelialization, assessed daily up to 60 days
Secondary outcomes (6)
Wound area
Description: Wound area (cm²) measured by tracing the wound margin on transparent film and calculated using ImageJ software.
Measured: Postoperative days 5, 7, and 14
Exudate score
Graded as 0=none, 1=mild (only on dressing), 2=moderate (soaking < half of dressing), 3=severe (soaking ≥ half of dressing).
Measured: Postoperative days 5, 7, and 14
Pain score (VAS)
Visual analog scale from 0 (no pain) to 10 (worst pain).
Measured: Postoperative days 5, 10, and 14
Inflammatory cytokines (TNF-α, IL-6, IL-1β)
Measured in serum by ELISA and in wound tissue by immunohistochemistry.
Measured: Postoperative days 7 and 14
PI3K-Akt-mTOR pathway proteins (p-PI3K, p-Akt, p-mTOR)
Expression levels and phosphorylation ratios measured by Western blot and immunohistochemistry in wound tissue.
Measured: Postoperative days 7 and 14
Collagen I and Collagen III
Protein and mRNA expression measured by Western blot, immunohistochemistry, and RT-qPCR in wound tissue
Measured: Postoperative days 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Wound Healing in Anal Fistula SurgeryStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yongkang An
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongkang An, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562672
- Sponsor's protocol ID
- YXLL2021010
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tongyangxiao Lotion Accelerates Postoperative Wound Healing in Anal Fistula Surgery by Activating the PI3K-Akt-mTOR Pathway
- ClinicalTrials.gov ID
- NCT07562672
- Acronym / sponsor ID
- YXLL2021010
- Keywords
- Tongyangxiao Lotion; Anal fistula; Wound Healing; PI3K-Akt-mTOR signaling pathway; Traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Yongkang AnUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 1 May 2026 (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 tests whether a traditional Chinese herbal bath called Tongyangxiao (TYX) lotion helps surgical wounds heal faster in patients who have had anal fistula surgery. Anal fistulas are abnormal tunnels near the anus that often require surgery, but the wound is usually left open and heals slowly. The study compares TYX lotion with a standard antiseptic bath (potassium permanganate). Patients use one of the two baths once daily for 14 days after surgery. The main goal is to see how long it takes for the wound to close completely. The study also measures pain, wound size, inflammation, and proteins involved in healing. A total of 115 patients took part, and laboratory experiments with human skin cells were also performed to understand how TYX works.
Detailed description
This prospective, single-blind, randomized controlled trial was conducted at two hospitals in China (The First Affiliated Hospital of Hebei University of Chinese Medicine and The First Affiliated Hospital of Henan University of Chinese Medicine) from June 2023 to June 2024. The study enrolled 115 patients aged 18-65 years with low simple anal fistula who underwent low anal fistulectomy. Patients were randomly assigned to either the Tongyangxiao (TYX) group (n=58) or the potassium permanganate (PP) group (n=57). Starting on postoperative day 2, the TYX group received a 15-minute sitz bath once daily with 1500 mL of TYX decoction (40°C) for 14 days. The TYX decoction contains ten herbs: Huangbai, Kushen, Danggui, Cangzhu, Qinjiao, Xixin, Fangfeng, Chuanjiao, Mingfan, and Mangxiao. The PP group received a 15-minute sitz bath with 1:5000 potassium permanganate solution (40°C) for the same duration.
The primary outcome was wound healing time (days from surgery to complete epithelialization). Secondary outcomes included wound area (measured by ImageJ at days 5,7,14), exudate score, pain by visual analog scale (VAS, days 5,10,14), serum and tissue levels of inflammatory cytokines (TNF-α, IL-6, IL-1β) by ELISA and immunohistochemistry, expression of PI3K-Akt-mTOR pathway proteins (p-PI3K, p-Akt, p-mTOR) by Western blot and immunohistochemistry, and collagen I/III expression by Western blot, qPCR, and immunohistochemistry. Safety was monitored by recording adverse events.
In parallel, network pharmacology predicted PI3K-Akt as a core pathway. An in vitro experiment using human fibroblast HFF-1 cells treated with TNF-α (50 ng/mL) was performed to model inflammation. Cells were treated with TYX lyophilized powder (0.1 or 0.5 mg/mL), the PI3K activator 740Y-P, or their combination. Cell migration was assessed by Transwell assay; pathway protein expression and collagen were measured by Western blot and immunofluorescence.
The study was approved by the Ethics Committee of Hebei University of Chinese Medicine (YXLL2021010) and the sub-center (2021HL-248-01). All patients gave written informed consent. No U.S. government funding or IND/IDE was involved.
Results demonstrate that TYX significantly shortened wound healing time, reduced pain and exudate, decreased inflammatory cytokines, and upregulated PI3K-Akt-mTOR phosphorylation and collagen deposition. In vitro, TYX reversed TNF-α-induced suppression of fibroblast migration and pathway activity. These findings support the clinical use of TYX lotion to accelerate postoperative wound healing in anal fistula surgery by activating the PI3K-Akt-mTOR signaling pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tongyangxiao (TYX) group | Experimental | Other: Tongyangxiao (TYX) group, Other: Potassium permanganate (PP) groupPatients receive a 15-minute sitz bath once daily with 1500 mL of Tongyangxiao decoction (40°C) from postoperative day 2 for 14 consecutive days. The decoction contains ten herbs: Huangbai (Phellodendron chinense), Kushen (Sophora flavescens), Danggui (Angelica sinensis), Cangzhu (Atractylodes lancea), Qinjiao (Gentiana macrophylla), Xixin (Asarum sieboldii), Fangfeng (Saposhnikovia divaricata), Chuanjiao (Zanthoxylum bungeanum), Mingfan (Alumen), and Mangxiao (Natrii Sulfas). |
| Potassium permanganate (PP) group | Active comparator | Other: Tongyangxiao (TYX) group, Other: Potassium permanganate (PP) groupPatients receive a 15-minute sitz bath once daily with 1500 mL of 1:5000 potassium permanganate solution (40°C) from postoperative day 2 for 14 consecutive days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 to 65 years
- Diagnosis of low simple anal fistula according to the Chinese expert consensus on diagnosis and treatment of anal fistula (2020 edition)
- Traditional Chinese medicine pattern of damp-heat downward infusion
- Underwent low anal fistulectomy
- No surgical contraindications
Key exclusion criteria (5 listed)
- Complex or high anal fistula
- Inflammatory bowel disease, diabetes mellitus, or severe cardiac / liver / renal dysfunction
- Allergy to any component of Tongyangxiao lotion or potassium permanganate
- Pregnancy or lactation
- Participation in another clinical trial within 3 months
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 |
|---|---|---|
| Tongyangxiao (TYX) groupPatients receive a 15-minute sitz bath once daily with 1500 mL of Tongyangxiao decoction (40°C) from postoperative day 2 for 14 consecutive days. The decoction contains ten herbs: Huangbai (Phellodendron chinense), Kushen (Sophora flavescens), Danggui (Angelica sinensis), Cangzhu (Atractylodes lancea), Qinjiao (Gentiana macrophylla), Xixin (Asarum sieboldii), Fangfeng (Saposhnikovia divaricata), Chuanjiao (Zanthoxylum bungeanum), Mingfan (Alumen), and Mangxiao (Natrii Sulfas). | Other | Potassium permanganate (PP) group, Tongyangxiao (TYX) group |
| Potassium permanganate (PP) groupAlso: Active Comparatoratients receive a 15-minute sitz bath once daily with 1500 mL of 1:5000 potassium permanganate solution (40°C) from postoperative day 2 for 14 consecutive days. | Other | Potassium permanganate (PP) group, Tongyangxiao (TYX) group |
Primary outcome
Wound healing time
Time frame: From date of surgery until complete epithelialization, assessed daily up to 60 days
Number of days from surgery to complete wound closure (complete epithelialization without need for dressing).Time Frame
6 secondary outcomes
Wound area
Time frame: Postoperative days 5, 7, and 14
Exudate score
Time frame: Postoperative days 5, 7, and 14
Pain score (VAS)
Time frame: Postoperative days 5, 10, and 14
Inflammatory cytokines (TNF-α, IL-6, IL-1β)
Time frame: Postoperative days 7 and 14
PI3K-Akt-mTOR pathway proteins (p-PI3K, p-Akt, p-mTOR)
Time frame: Postoperative days 7 and 14
Collagen I and Collagen III
Time frame: Postoperative days 7 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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 study testing Tongyangxiao (TYX) group and Potassium permanganate (PP) group in people with Postoperative Wound Healing in Anal Fistula Surgery, run by Yongkang An 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 1 May 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 date of surgery until complete epithelialization, assessed daily up to 60 days). 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 1 May 2026.