Acute Anal FissurePhase 4PBSAAFNCT03355846
Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
A Phase 4 study testing Centella, Proctocella and Flavonil® cps in people with Acute Anal Fissure, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Anal Fissure
- What is being tested?
- Centella, Proctocella and Flavonil® cps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2018to 1 May 2018
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects With Acute Anal Fissure
- Collaborative patients able to understand and want;
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of General Surgery "Paride Stefanini", University of Rome "La Sapienza"
Rome, RM, 00161
About this study
Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
Read the detailed description
Starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
The comparative study will be conducted by comparing the following products:
- Centella® Complex 1 cps 60 mg per os after meals twice a day for 15 days;
- Proctocella® Complex cream to be applied in anal area and anal canal after hygiene treatment for 4 weeks;
- Flavonil® 1 cps 300 mg per os after meals twice a day for 15 days;
- Flavonil® Cream Cream to be applied in anal region and anal canal after hygiene treatment for 4 weeks;
- Rectalgan Mousse cleansing cleanser for anal and perineal region for 4 weeks.
Our approach attempts to blend, based on the evidence of the most recent scientific literature, the experience of decades of colonproctologic clinical practice that has a predominantly surgical approach, with the clinical evidence of the Science of Nutrition which has a conservative vision in the treatment of ailments and constipation, a predisposing factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. The control group will receive the traditional basic treatment consisting in the application of lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and diet. The two groups with which they will be compared for the results will receive, in addition to the foregoing (for controls), or Flavonoids (ProtFlav) or Asian Centella Extract (ProtCent), in the form of local mouth and cream tablets to be applied at the perianal level and possibly in the anal canal with gloved finger, containing the same active principles also administered by mouth.
- Conditions
- Acute Anal Fissure
- Being tested
- Centella, Proctocella, Flavonil® cps, Flavonil® Cream, Rectalgan Mousse
- Keywords
- Anal Fissure, local therapy, pain, defecation, bleeding
- Medical subject headings
- Fissure in Ano, Pain, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CentellaDrug
after meals twice a day for 15 days
ProctocellaDrug
after hygiene treatment for 4 weeks;
Flavonil® cpsDrug
after meals twice a day for 15 days
Flavonil® CreamDrug
treatment for 4 weeks;
.
Rectalgan MousseDrug
for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| AAF treated with Centella® Complex | Experimental | Centella® Complex 1 cps 60 mg per os Receives: Drug: Centella |
| AAF treated with Proctocella® cream | Experimental | Proctocella® Complex cream to be applied in anal area and anal canal Receives: Drug: Proctocella |
| AAF treated with Flavonil® cps | Experimental | Flavonil® 1 cps 300 mg per os Receives: Drug: Flavonil® cps |
| AAF treated with Flavonil® Cream | Experimental | Flavonil® Cream Cream to be applied in anal region and anal canal Receives: Drug: Flavonil® Cream |
| AAF treated with Rectalgan Mousse | Experimental | Rectalgan Mousse cleansing cleanser for anal and perineal region Receives: Drug: Rectalgan Mousse |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for the disappearance of pain
time for the disappearance of pain in course of treatment
Measured: 1 month
Secondary outcomes (1)
time for the disappearance of bleeding
time for the disappearance of bleeding in course of treatment
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start1 May 2018
- Primary completion1 May 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Anal FissureStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massimo Chiaretti, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03355846
- Sponsor's protocol ID
- URomLS-2017-1
- Acronym
- PBSAAF
- Status last verified
- Nov 2017
- First submitted
- 22 Nov 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DW, Chi YS, Son KH, Chang HW, Kim JS, Kang SS, Kim HP. Effects of sophoraflavanone G, a prenylated flavonoid from Sophora flavescens, on cyclooxygenase-2 and in vivo inflammatory response. Arch Pharm Res. 2002 Jun;25(3):329-35. doi: 10.1007/BF02976635.
PubMed 12135106Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS. Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study. Curr Med Res Opin. 2001;17(4):256-61.
PubMed 11922398Mullen W, McGinn J, Lean ME, MacLean MR, Gardner P, Duthie GG, Yokota T, Crozier A. Ellagitannins, flavonoids, and other phenolics in red raspberries and their contribution to antioxidant capacity and vasorelaxation properties. J Agric Food Chem. 2002 Aug 28;50(18):5191-6. doi: 10.1021/jf020140n.
PubMed 12188628Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002 May-Jun;53(3):245-56. doi: 10.1177/000331970205300301.
PubMed 12025911Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000 Jul;87(7):868-72. doi: 10.1046/j.1365-2168.2000.01448.x.
PubMed 10931020Chiaretti M, Fegatelli DA, Ceccarelli G, Carru GA, Pappalardo G, Chiaretti AI. Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial. Ann Ital Chir. 2018;89:330-336.
PubMed 29844250
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Bleeding in Subjects With Acute Anal Fissure: Comparative Evaluation of Three Treatments
- ClinicalTrials.gov ID
- NCT03355846
- Acronym / sponsor ID
- PBSAAF / URomLS-2017-1
- Conditions
- Acute Anal Fissure
- Keywords
- Anal Fissure, local therapy, pain, defecation, bleeding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 28 Nov 2017 (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.
Starting from the observation that acute anal fissure (AAF) in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
Detailed description
Starting from the observation that anal fissure in 6-8 weeks can heal spontaneously and that some of the commonly used commercial products in clinical practice would seem to be useful, the rationale of the comparative study is to try to identify, in compliance with the protocol of Helsinki (2013), the most effective short-term treatment for the disappearance of pain in defecation and cessation of bleeding, shortening the duration of the healing process and favoring the patient's rapid return to his / her activity, respect for patient safety.
The comparative study will be conducted by comparing the following products:
- Centella® Complex 1 cps 60 mg per os after meals twice a day for 15 days;
- Proctocella® Complex cream to be applied in anal area and anal canal after hygiene treatment for 4 weeks;
- Flavonil® 1 cps 300 mg per os after meals twice a day for 15 days;
- Flavonil® Cream Cream to be applied in anal region and anal canal after hygiene treatment for 4 weeks;
- Rectalgan Mousse cleansing cleanser for anal and perineal region for 4 weeks.
Our approach attempts to blend, based on the evidence of the most recent scientific literature, the experience of decades of colonproctologic clinical practice that has a predominantly surgical approach, with the clinical evidence of the Science of Nutrition which has a conservative vision in the treatment of ailments and constipation, a predisposing factor in the pathogenesis of anal fissure, in order to obtain healing without surgery. The control group will receive the traditional basic treatment consisting in the application of lubricated anal dilators of increasing gauge according to predetermined pattern, hygiene and diet. The two groups with which they will be compared for the results will receive, in addition to the foregoing (for controls), or Flavonoids (ProtFlav) or Asian Centella Extract (ProtCent), in the form of local mouth and cream tablets to be applied at the perianal level and possibly in the anal canal with gloved finger, containing the same active principles also administered by mouth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AAF treated with Centella® Complex | Experimental | Drug: CentellaCentella® Complex 1 cps 60 mg per os |
| AAF treated with Proctocella® cream | Experimental | Drug: ProctocellaProctocella® Complex cream to be applied in anal area and anal canal |
| AAF treated with Flavonil® cps | Experimental | Drug: Flavonil® cpsFlavonil® 1 cps 300 mg per os |
| AAF treated with Flavonil® Cream | Experimental | Drug: Flavonil® CreamFlavonil® Cream Cream to be applied in anal region and anal canal |
| AAF treated with Rectalgan Mousse | Experimental | Drug: Rectalgan MousseRectalgan Mousse cleansing cleanser for anal and perineal region |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects With Acute Anal Fissure
- Collaborative patients able to understand and want;
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Centellaafter meals twice a day for 15 days | Drug | AAF treated with Centella® Complex |
| Proctocellaafter hygiene treatment for 4 weeks; | Drug | AAF treated with Proctocella® cream |
| Flavonil® cpsafter meals twice a day for 15 days | Drug | AAF treated with Flavonil® cps |
| Flavonil® Creamtreatment for 4 weeks; . | Drug | AAF treated with Flavonil® Cream |
| Rectalgan Moussefor 4 weeks | Drug | AAF treated with Rectalgan Mousse |
Primary outcome
time for the disappearance of pain
Time frame: 1 month
time for the disappearance of pain in course of treatment
1 secondary outcome
time for the disappearance of bleeding
Time frame: 1 month
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 13 Jul 2018.
- Background: PubMed 12135106Kim DW, Chi YS, Son KH, Chang HW, Kim JS, Kang SS, Kim HP. Effects of sophoraflavanone G, a prenylated flavonoid from Sophora flavescens, on cyclooxygenase-2 and in vivo inflammatory response. Arch Pharm Res. 2002 Jun;25(3):329-35. doi: 10.1007/BF02976635.
- Background: PubMed 11922398Basile M, Gidaro S, Pacella M, Biffignandi PM, Gidaro GS. Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: a randomized, double-blind, placebo-controlled, phase IV study. Curr Med Res Opin. 2001;17(4):256-61.
- Background: PubMed 12188628Mullen W, McGinn J, Lean ME, MacLean MR, Gardner P, Duthie GG, Yokota T, Crozier A. Ellagitannins, flavonoids, and other phenolics in red raspberries and their contribution to antioxidant capacity and vasorelaxation properties. J Agric Food Chem. 2002 Aug 28;50(18):5191-6. doi: 10.1021/jf020140n.
- Background: PubMed 12025911Jantet G. Chronic venous insufficiency: worldwide results of the RELIEF study. Reflux assEssment and quaLity of lIfe improvEment with micronized Flavonoids. Angiology. 2002 May-Jun;53(3):245-56. doi: 10.1177/000331970205300301.
- Background: PubMed 10931020Misra MC, Parshad R. Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids. Br J Surg. 2000 Jul;87(7):868-72. doi: 10.1046/j.1365-2168.2000.01448.x.
- Results publication: PubMed 29844250Chiaretti M, Fegatelli DA, Ceccarelli G, Carru GA, Pappalardo G, Chiaretti AI. Comparison of Flavonoids and Centella asiatica for the treatment of chronic anal fissure. A randomized clinical trial. Ann Ital Chir. 2018;89:330-336.
- Individual participant dataSharing planned: No
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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 Phase 4 study testing Centella, Proctocella and Flavonil® cps in people with Acute Anal Fissure, run by University of Roma La Sapienza at 1 site in Italy.
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 2 inclusion and 1 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 13 Jul 2018. 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 Italy. 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.
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?
time for the disappearance of pain (time frame: 1 month). 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 NCT03355846, which also lists 6 linked publications.
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 13 Jul 2018.