Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

December 20, 2018 updated by: Erhan Aysan, SB Istanbul Education and Research Hospital

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Older than 18 years old cases

Description

Inclusion Criteria:

  • Grade 1 and 2 hemorroidal disease
  • Cronic anal fissura
  • Uncomplicated simple perianal fistula

Exclusion Criteria:

  • Any malign tumour
  • Cronic colorectal disases
  • Routine used of vasoactive medication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group-1 (n: 50): Healthy cases
Control group
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Names:
  • Life 7
Group-2 (n:50): Grade 1 hemorroid
With perianal examination diagnosed of grade 1 hemorroidal disease
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Names:
  • Life 7
Group-3 (n:50): Grade 2 hemorroid
With perianal examination diagnosed of grade 2 hemorroidal disease
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Names:
  • Life 7
Group-4 (n:50): Anal fissure cases
With perianal examination diagnosed of anal fissure cases
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Names:
  • Life 7
Group-5 (n:50): Simple perianal fistula
With perianal examination diagnosed of uncomplicated, simple perianal fistula cases
Drug: Life7
Life7 will used on the perianal skin with finger tips
Other Names:
  • Life 7

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain symtom differences
Time Frame: six months
Pain Scale from level 1 to level 10.
six months
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
six months
Closing of anal fissur line
Time Frame: six months
Surgeon general physical examination. Fissur line is exist or not exist
six months
Lowering of leakage amount of perianal fistule
Time Frame: six months
Three grade: lower, same, more
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SB Istanbul Education and Research Hospital

Collaborators

Tabriz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 18, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • yeditepe university

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhoids

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe