HemorrhoidsNCT03780998
Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases
An observational study of Hemorrhoids and Anal Fissure, run by SB Istanbul Education and Research Hospital.
Trial summary
New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Anal Fissure, Perianal Fistula
- What is being tested?
- Life7
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Older than 18 years old cases
Who may be able to join
- Grade 1 and 2 hemorroidal disease
- Cronic anal fissura
- Uncomplicated simple perianal fistula
Who cannot join
- Any malign tumour
- Cronic colorectal disases
- Routine used of vasoactive medication
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial
New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)
Read the detailed description
Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study.
Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases
- Conditions
- Hemorrhoids, Anal Fissure, Perianal Fistula
- Being tested
- Life7
- Medical subject headings
- Hemorrhoids, Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life7Drug
Also called Life 7
Life7 will used on the perianal skin with finger tips
| Study group | Role | What they receive |
|---|---|---|
| Group-1 (n: 50): Healthy cases | Control group Receives: Drug: Life7 | |
| Group-2 (n:50): Grade 1 hemorroid | With perianal examination diagnosed of grade 1 hemorroidal disease Receives: Drug: Life7 | |
| Group-3 (n:50): Grade 2 hemorroid | With perianal examination diagnosed of grade 2 hemorroidal disease Receives: Drug: Life7 | |
| Group-4 (n:50): Anal fissure cases | With perianal examination diagnosed of anal fissure cases Receives: Drug: Life7 | |
| Group-5 (n:50): Simple perianal fistula | With perianal examination diagnosed of uncomplicated, simple perianal fistula cases Receives: Drug: Life7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain symtom differences
Pain Scale from level 1 to level 10.
Measured: six months
Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)
Surgeon general physical examination
Measured: six months
Closing of anal fissur line
Surgeon general physical examination. Fissur line is exist or not exist
Measured: six months
Lowering of leakage amount of perianal fistule
Three grade: lower, same, more
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tabriz University of Medical Sciences
- Responsible party
- Principal investigator, Erhan Aysan, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780998
- Sponsor's protocol ID
- yeditepe university
- Status last verified
- Dec 2018
- First submitted
- 13 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT03780998
- Acronym / sponsor ID
- yeditepe university
- Conditions
- Hemorrhoids, Anal Fissure, Perianal Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Collaborators
- Tabriz University of Medical Sciences
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 19 Dec 2018 (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.
New produced and patented sodium pantaborat based gel will be use for treatment of benign perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)
Detailed description
Prospective randomised clinical trial planned. Older than 18 years old perianal benign diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal fistula) cases without malign tumour, cronic colorectal disases, and routine used of vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases were exclused of the study.
Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases Group-5 (n:50): Uncomplicated, simple perianal fistula cases
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group-1 (n: 50): Healthy cases | – | Drug: Life7Control group |
| Group-2 (n:50): Grade 1 hemorroid | – | Drug: Life7With perianal examination diagnosed of grade 1 hemorroidal disease |
| Group-3 (n:50): Grade 2 hemorroid | – | Drug: Life7With perianal examination diagnosed of grade 2 hemorroidal disease |
| Group-4 (n:50): Anal fissure cases | – | Drug: Life7With perianal examination diagnosed of anal fissure cases |
| Group-5 (n:50): Simple perianal fistula | – | Drug: Life7With perianal examination diagnosed of uncomplicated, simple perianal fistula cases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Older than 18 years old cases
Key inclusion criteria (3 listed)
- Grade 1 and 2 hemorroidal disease
- Cronic anal fissura
- Uncomplicated simple perianal fistula
Key exclusion criteria (3 listed)
- Any malign tumour
- Cronic colorectal disases
- Routine used of vasoactive medication
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 |
|---|---|---|
| Life7Also: Life 7Life7 will used on the perianal skin with finger tips | Drug | Group-1 (n: 50): Healthy cases, Group-2 (n:50): Grade 1 hemorroid, Group-3 (n:50): Grade 2 hemorroid, Group-4 (n:50): Anal fissure cases, Group-5 (n:50): Simple perianal fistula |
Primary outcome
Pain symtom differences
Time frame: six months
Pain Scale from level 1 to level 10.
Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)
Time frame: six months
Surgeon general physical examination
Closing of anal fissur line
Time frame: six months
Surgeon general physical examination. Fissur line is exist or not exist
Lowering of leakage amount of perianal fistule
Time frame: six months
Three grade: lower, same, more
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids and Anal Fissure, run by SB Istanbul Education and Research Hospital.
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 3 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: status not confirmed, as of the sponsor's last update on 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact erhan aysan, MD Prof (+905322034879 ext. 4130, erhanaysan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain symtom differences (time frame: six months). The study lists 4 primary outcomes in all. 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 21 Dec 2018.