Anal FistulaPhase 4NCT06184438
Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
A Phase 4 study testing Micronized purified flavonoid fraction(Daflon 1000mg) in people with Anal Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Micronized purified flavonoid fraction(Daflon 1000mg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Dec 2023to 31 Mar 2025
- Phase
- Phase 4
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who undergo fistulectomy or fistulotomy are included.
Who cannot join
- Emergency operation
- Participants who had Trans-sphincteric anal fistula, Extra-sphincteric anal fistula
- Participants accompanied by severe liver cirrhosis
- Participants accompanied by coagulation disorders
- Participants taking anticoagulant
- Participants taking corticosteroids as long-term medication.
Show all 11Show fewer
- Participants who had colorectal cancer
- Participants taking analgesic drugs (morphine or others) as long-term medication
- Participants bed-ridden
- Participants who had history of human immunodeficiency virus (HIV) infection
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.
Read the detailed description
The current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. Also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. This condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy.
MPFF is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. More research has also shown the effects of MPFF on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. Since other anorectal surgery has similar complications. Therefor we conducted this randomized control trial to evaluate the benefits of MPFF after anal fistula surgeries.
- Conditions
- Anal Fistula
- Being tested
- Micronized purified flavonoid fraction(Daflon 1000mg), Placebo
- Keywords
- flavnoids, fistulotomy, fistulectomy
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micronized purified flavonoid fraction(Daflon 1000mg)Drug
Also called diosmin, hesperidin
Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7
PlaceboDrug
Also called Control group
Received placebo after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Daflon group | Experimental | Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7. Receives: Drug: Micronized purified flavonoid fraction(Daflon 1000mg) |
| Placebo group | Placebo comparator | Received placebo after surgery from day 0 to day 7. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.
Measured: 0-7 days
Frequency of dressing replacement
Record the frequency of dressing replacement from post-operative day 0 to day 7.
Measured: 0-7 days
Secondary outcomes (8)
Analgesic agent use
Daily consumption of oral analgesics from post-operative day 0 to day 7
Measured: 0-7days
Incidence of surgical site infection
Surgical site infection was defined as hospital admission for infection management or need for surgical intervention to manage the wound.
Measured: 0-30 days
Incidence of urinary retention
Urinary retention was defined as patients requiring Foley catheterization during the hospital stay.
Measured: 0-7days
Daily activity
The number of days the patient takes to go back to work.
Measured: 0-7 days
Bowel movement
Duration until first bowel movement after surgery.
Measured: 0-7 days
Patient satisfaction
Questionnaire will be collected after the surgery.
Measured: Post Operative day 7
Length of hospital stay
Length of hospital stay after the surgery.
Measured: 0-7 days
Wound healing questionnaire
Evaluate wound healing at 30 days after operation.
Measured: 0-60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start13 Dec 2023
- Primary completion1 Jan 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We designed a randomized controlled trial including 150 eligible patients who underwent fistulotomy or fistulectomy. To evaluate the benefit of using MPFF after fistula surgery, patients were classified into 2 groups: 1. Received MPFF(Daflon 1000mg BID) after surgery. 2. Received placebo after surgery.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tungcheng Chang, MD, PhD, Taipei Medical University Shuang Ho Hospital
- Investigators
- Tungcheng Chang, MD, PHD, Study director, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184438
- Sponsor's protocol ID
- N202309013
- Status last verified
- May 2025
- First submitted
- 14 Dec 2023
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used in this study can be obtained from the investigator upon reasonable request.
Publications
Tsai YW, Kiu KT, Chang TC. Efficacy of micronized purified flavonoid fraction in reducing pain after anal fistula surgery: a randomized controlled trial. Tech Coloproctol. 2026 Mar 3;30(1):36. doi: 10.1007/s10151-026-03298-5.
PubMed 41776089
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Micronized Purified Flavonoid Fraction for Post Operative Treatment in Anal Fistula Surgery
- ClinicalTrials.gov ID
- NCT06184438
- Acronym / sponsor ID
- N202309013
- Conditions
- Anal Fistula
- Keywords
- flavnoids, fistulotomy, fistulectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 28 Dec 2023 (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.
The aim of this study is to evaluate the effect of micronized purified flavonoid fraction on postoperative symptoms after surgery of anorectal fistulas.
Detailed description
The current theory of cryptoglandular suggest that perianal fistula occurs when the anal crypt glands become occluded and infected, over 90% of perianal fistulas are cryptoglandular in origin and arise from perianal abscesses. Also inflammatory process might play an important role in the formation of cryptoglandular perianal fistula. This condition is mainly managed with surgery, currently remain majorly on two conventional surgical interventions--fistulotomy and fistulectomy.
MPFF is a drug to treat venous vessel disease such as varicose and hemorrhoid, which was found with effects of lowering lymphatic permeability, improving venous return and vessel endothelial inflammation. More research has also shown the effects of MPFF on post hemorrhoidectomy symptom control, such as bleeding, pain, and infection. Since other anorectal surgery has similar complications. Therefor we conducted this randomized control trial to evaluate the benefits of MPFF after anal fistula surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- We designed a randomized controlled trial including 150 eligible patients who underwent fistulotomy or fistulectomy. To evaluate the benefit of using MPFF after fistula surgery, patients were classified into 2 groups: 1. Received MPFF(Daflon 1000mg BID) after surgery. 2. Received placebo after surgery.
| Arm | Type | Receives |
|---|---|---|
| Daflon group | Experimental | Drug: Micronized purified flavonoid fraction(Daflon 1000mg)Received Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day 0 to day 7. |
| Placebo group | Placebo comparator | Drug: PlaceboReceived placebo after surgery from day 0 to day 7. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who undergo fistulectomy or fistulotomy are included.
Key exclusion criteria (11 listed)
- Emergency operation
- Participants who had Trans-sphincteric anal fistula, Extra-sphincteric anal fistula
- Participants accompanied by severe liver cirrhosis
- Participants accompanied by coagulation disorders
- Participants taking anticoagulant
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 |
|---|---|---|
| Micronized purified flavonoid fraction(Daflon 1000mg)Also: diosmin, hesperidinReceived Micronized purified flavonoid fraction(Daflon 1000mg) BID after surgery from day to day 7 | Drug | Daflon group |
| PlaceboAlso: Control groupReceived placebo after surgery. | Drug | Placebo group |
Primary outcome
Post-operative pain
Time frame: 0-7 days
Record the maximum pain score(visual analog scale, 0-10) from post-operative day 0 to day 7.
Frequency of dressing replacement
Time frame: 0-7 days
Record the frequency of dressing replacement from post-operative day 0 to day 7.
8 secondary outcomes
Analgesic agent use
Time frame: 0-7days
Incidence of surgical site infection
Time frame: 0-30 days
Incidence of urinary retention
Time frame: 0-7days
Daily activity
Time frame: 0-7 days
Bowel movement
Time frame: 0-7 days
Patient satisfaction
Time frame: Post Operative day 7
Length of hospital stay
Time frame: 0-7 days
Wound healing questionnaire
Time frame: 0-60 days
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 16 May 2025.
- Derived from this study: PubMed 41776089Tsai YW, Kiu KT, Chang TC. Efficacy of micronized purified flavonoid fraction in reducing pain after anal fistula surgery: a randomized controlled trial. Tech Coloproctol. 2026 Mar 3;30(1):36. doi: 10.1007/s10151-026-03298-5.
- Individual participant dataSharing planned: Yes. The datasets used in this study can be obtained from the investigator upon reasonable request.
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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.
Tungcheng Chang, MD, PHD study director
Taipei Medical University Shuang Ho Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Micronized purified flavonoid fraction(Daflon 1000mg) in people with Anal Fistula, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 1 inclusion and 11 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 16 May 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 Taiwan. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-operative pain (time frame: 0-7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184438, which also lists 1 linked publication.
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 16 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.