Fistula in AnoCPDNCT06663527
Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy
A study testing Fumigating-washing Therapy With CPD in people with Fistula in Ano, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- Fumigating-washing Therapy With CPD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 26 Oct 2024to 1 Feb 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:age range of 18 to 80 years who had undergone anal fistulotomy procedures.
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Exclusion Criteria:patients with Crohn's disease, pregnancy or lactation, organ dysfunction (such as heart failure, respiratory insufficiency, liver or renal impairment, gastrointestinal dysfunction), coagulopathy, autoimmune diseases, or a history of hypersensitivity to Chinese medicinal substances.
-
Trial locations and contacts
1 site in 1 country.
About this study
Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.
- Conditions
- Fistula in Ano
- Being tested
- Fumigating-washing Therapy With CPD, fumigating-washing therapy with a placebo
- 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.
Fumigating-washing Therapy With CPDCombination product
All patients underwent anal fistulectomy based on the Parks classification. For postoperative infection prophylaxis, cefuroxime was used at a dosage of 2g per dose, twice daily. Commencing the day following surgery, a fumigating-washing therapy was conducted once daily either after defecation or two hours prior to intravenous infusion. In the study group, a medical solution used for fumigating-washing therapy was prepared by blending 200 ml of CPD with 2 liters of water at 40 °C. This medicinal solution was then transferred into the reservoir of an ultrasonic atomizing fumigating-washing device (Model:TM50-C, Xuzhou Tianma Medical Equipment Factory, China) that was classified by the FDA as Class II (special controls).
fumigating-washing therapy with a placeboCombination product
fumigating-washing therapy with a placebo
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Study group (n=30) treated fumigating-washing therapy with the CPD Receives: Combination Product: Fumigating-washing Therapy With CPD |
| Control Group | Placebo comparator | Control group (n=30) underwent fumigating-washing therapy with a placebo Receives: Combination Product: fumigating-washing therapy with a placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The healing duration of wounds
The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
Measured: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start26 Oct 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies 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
- 60 participants (actual)
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
- NCT06663527
- Sponsor's protocol ID
- 2022-zj-19
- Other IDs
- 2023AH050848
- Acronym
- CPD
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy
- ClinicalTrials.gov ID
- NCT06663527
- Acronym / sponsor ID
- CPD / 2022-zj-19
- Conditions
- Fistula in Ano
- Keywords
- Anal fistula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 26 Oct 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 29 Oct 2024 (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.
Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Combination Product: Fumigating-washing Therapy With CPDStudy group (n=30) treated fumigating-washing therapy with the CPD |
| Control Group | Placebo comparator | Combination Product: fumigating-washing therapy with a placeboControl group (n=30) underwent fumigating-washing therapy with a placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fumigating-washing Therapy With CPDAll patients underwent anal fistulectomy based on the Parks classification. For postoperative infection prophylaxis, cefuroxime was used at a dosage of 2g per dose, twice daily. Commencing the day following surgery, a fumigating-washing therapy was conducted once daily either after defecation or two hours prior to intravenous infusion. In the study group, a medical solution used for fumigating-washing therapy was prepared by blending 200 ml of CPD with 2 liters of water at 40 °C. This medicinal solution was then transferred into the reservoir of an ultrasonic atomizing fumigating-washing device (Model:TM50-C, Xuzhou Tianma Medical Equipment Factory, China) that was classified by the FDA as Class II (special controls). | Combination product | Study Group |
| fumigating-washing therapy with a placebofumigating-washing therapy with a placebo | Combination product | Control Group |
Primary outcome
The healing duration of wounds
Time frame: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.
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 12 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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. 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 Fumigating-washing Therapy With CPD in people with Fistula in Ano, 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?
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 12 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.
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?
The healing duration of wounds (time frame: The healing duration of wounds, edema, exudation, and pain scores, served as the principal observation index.). 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 12 Aug 2025.