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Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms

Protocol summary

Study aim
Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms
Design
To determine the sample size, the effect of sodium phentetraate ointment on improving the internal hemorrhoid grade 1 to 4 in patients with hemorrhoids was considered as the main objective. The basic information needed to calculate the sample size from Doğan et al. Was extracted in 2014. Using the G-Power software, with a 95% confidence interval, the test power of 80% and a 25% drop, the sample size was calculated to be 215, which will be performed in the study for the first time in patients with hemorrhoids, With a 50% sample rate (53 in each group).
Settings and conduct
This study is a double-blind, randomized, placebo-controlled study using sodium omeprazole or placebo ointment in people with symptomatic internal hemorrhoids. The subjects are randomly assigned in a 1: 1 ratio in intervention or control groups. Patients referred to the Hemorrhagic Clinic of Tabriz University of Medical Sciences with symptoms and symptoms of hemorrhoids are included in the study or are excluded from the study through the entry / exit criteria and if informed consent is given.
Participants/Inclusion and exclusion criteria
18-65 years old-Patients with hemorrhoids and with the diagnosis of internal hemorrhoid disease Grade I, II, III or IV. The presence of anal bleeding as one of the symptoms of a hemorrhoid in the patient- Non-use of a drug other than the drug and control drug for the treatment of hemorrhoids during the study period
Intervention groups
Intervention: 3% sodium pentahydrate Phenytoinate gel twice daily for 1 month Control: Treating patients with hemorrhoids in a way other than mentioned
Main outcome variables
Severity of itching-Severity of pain during rest - Severity of pain when starting the excretion of the stool - Frequency of sensation in the anus - Exhaustion of the hemorrhoid mass

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190701044062N1
Registration date: 2019-07-13, 1398/04/22
Registration timing: registered_while_recruiting

Last update: 2019-07-13, 1398/04/22
Update count: 0
Registration date
2019-07-13, 1398/04/22
Registrant information
Name
manouchehr khoshbaten
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 3010
Email address
mkhoshbaten@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-04, 1398/03/14
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms
Public title
Evaluation of Sodium Pentaborate Topical Ointment on Hemorrhoid Symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
65-18 years old Patients with hemorrhoids and those with I, II, III or IV internal hemorrhoid disorder without need for emergency interventions based on physical examination The presence of anal bleeding as one of the symptoms of a hemorrhoid in the patient (according to the Sodergren scoring system) Non-use of a drug other than the drug and control drug for the treatment of hemorrhoids during the study period
Exclusion criteria:
Disorders and analgesics including inflammatory bowel disease, Fisher, fistula and perianal rash, rectal prolapse, rectus, benign or malignant tumor of the anus and rectum, and perianal infections Patients with sodium phentetrazur susceptibility or a history of skin sensitivity to vaseline Pregnancy or breastfeeding Patients with severe heart disease, neurology, liver and kidney disease and blood diseases Taking any local analgesic for the past 7 days Prohibition of topical use of vaseline or sodium panteurate The history of permanent prolapse is the entire thickness of the rectum
Age
From 18 years old to 65 years old
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 53
Randomization (investigator's opinion)
Randomized
Randomization description
Given the fact that the sample size is the same in both groups, we use the Excel software and the formula = Rand () to randomize and to increase the precision and balance of the samples in the randomization (for any reason Patient will withdraw from the plan) we use several blocks per group. It will also be provided to the physician to cover the allocation of matte envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
A gel that has an active ingredient in boron with a gel that does not have a substance and is used as a placebo is completely identical in terms of the shape and size of the container, and the gels themselves do not differ in terms of odor and color, and are completely indistinguishable. (This action was taken by the pharmaceutical company). The important point is that the patient is told that the gel used for the patient may be medication or medication. Clinicians and blind patients will be blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Central Office of Tabriz University of Medical Sciences Tabriz -Golghast St.- Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-06-03, 1398/03/13
Ethics committee reference number
IR.TBZMED.REC.1398.235

Health conditions studied

1

Description of health condition studied
Hemorrhoid
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis

Primary outcomes

1

Description
Severe itching
Timepoint
25 to 30 days
Method of measurement
questionnaire and Sodergren Scoring System

2

Description
Severity of pain during rest
Timepoint
25 to 30 days
Method of measurement
Severity of pain during rest

3

Description
Pain intensity when starting fecal excretion
Timepoint
25 to 30 days
Method of measurement
Pain intensity when starting fecal excretion

4

Description
Frequent feeling of mass in the anus
Timepoint
25 to 30 days
Method of measurement
Frequent feeling of mass in the anus

5

Description
The severity of the outgrowth of the hemorrhoid mass
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation

6

Description
The degree of anoscopic hemorrhoids
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation

7

Description
Number of hemorrhoid hemorrhages
Timepoint
25 to 30 days
Method of measurement
Clinical evaluation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 3% sodium pentahydrate Phenytoinate gel twice daily for 1 month
Category
Treatment - Drugs

2

Description
Control group: Treating patients with hemorrhoids in a way other than the mentioned procedure
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Gastroenterology and Endoscopy, Imam Reza Hospital, Tabriz
Full name of responsible person
Manouchehr Khoshbaten
Street address
Golgasht St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
A. Ghasem Jouyban
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 3335 9680
Email
mkhoshbaten@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manouchehr Khoshbaten
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult digestive and liver
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Phone
+98 41 1334 3010
Email
mkhoshbaten@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data will be shared.
When the data will become available and for how long
2020
To whom data/document is available
University researchers and professors
Under which criteria data/document could be used
For further studies
From where data/document is obtainable
by Email
What processes are involved for a request to access data/document
Request via email
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