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NCT03780998 Clinical Trial

Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases

Hemorrhoids Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03780998
Other study ID # yeditepe university
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2020

Study information
Verified date December 2018
Source SB Istanbul Education and Research Hospital
Contact erhan aysan, MD Prof
Phone +905322034879
Email erhanaysan@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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)

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 250
Est. completion date January 1, 2020
Est. primary completion date January 1, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Life7
Life7 will used on the perianal skin with finger tips

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
SB Istanbul Education and Research Hospital Tabriz University of Medical Sciences

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