Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases
1 other identifier
observational
250
0 countries
N/A
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedDecember 21, 2018
December 1, 2018
Same day
December 13, 2018
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Pain symtom differences
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)
Surgeon general physical examination
six months
Closing of anal fissur line
Surgeon general physical examination. Fissur line is exist or not exist
six months
Lowering of leakage amount of perianal fistule
Three grade: lower, same, more
six months
Study Arms (5)
Group-1 (n: 50): Healthy cases
Control group
Group-2 (n:50): Grade 1 hemorroid
With perianal examination diagnosed of grade 1 hemorroidal disease
Group-3 (n:50): Grade 2 hemorroid
With perianal examination diagnosed of grade 2 hemorroidal disease
Group-4 (n:50): Anal fissure cases
With perianal examination diagnosed of anal fissure cases
Group-5 (n:50): Simple perianal fistula
With perianal examination diagnosed of uncomplicated, simple perianal fistula cases
Interventions
Life7 will used on the perianal skin with finger tips
Eligibility Criteria
Older than 18 years old cases
You may qualify if:
- Grade 1 and 2 hemorroidal disease
- Cronic anal fissura
- Uncomplicated simple perianal fistula
You may not qualify if:
- Any malign tumour
- Cronic colorectal disases
- Routine used of vasoactive medication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
histopathological evaluation
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Prof
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 19, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2019
Study Completion
January 1, 2020
Last Updated
December 21, 2018
Record last verified: 2018-12