Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03780998

Enrollment

250

Registered

2018-12-19

Start date

2019-01-01

Completion date

2020-01-01

Last updated

2018-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fissure, Hemorrhoids, Perianal Fistula

Brief 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)

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

Interventions

DRUGLife7

Life7 will used on the perianal skin with finger tips

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Lowering of leakage amount of perianal fistule	six months	Three grade: lower, same, more
Pain symtom differences	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)	six months	Surgeon general physical examination
Closing of anal fissur line	six months	Surgeon general physical examination. Fissur line is exist or not exist

Contacts

Primary Contacterhan aysan, MD Prof

erhanaysan@hotmail.com+905322034879

Backup ContactFikrettin Sahin, Prof

fikrettinsahin@gmail.com+905338146547

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026