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The Effectiveness of Ozone Olive Oil on healing of Acute Perianal Fissure

Protocol summary

Study aim
The Effectiveness of Ozone Olive Oil on healing of Acute Perianal Fissure
Design
A two-arm, triple-blind, randomized controlled trial on 60 patients.
Settings and conduct
The patients, the surgeon, the nurse who records the data and data analyser are blinded to the allocated groups.
Participants/Inclusion and exclusion criteria
In this study, all patients with acute fissure with age range of 18-65 years and without gender restrictions, who are candidates for medical treatment, will enter the study. Exclusion criteria include the previous history of anal surgery, comorbidities (diabetes), IBD disease, STD disease around the anus, TB disease, anorectal cancers, immunodeficiency
Intervention groups
The first group undergo standard treatment for patients with acute perianal fissure, sitting in warm water, use of laxative and stool bulking twice a day with plain olive oil ointment as a placebo (prepared and formulated by Nasim Ozon Urmia Company). One cc is given twice a day. The second group, in addition to the standard treatment of patients with acute perianal fissure, treat with the topical formulation of ozone olive oil ointment (by Nasim Ozon Company).
Main outcome variables
The severity of pain, bleeding, itching and wound healing

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190423043356N1
Registration date: 2020-07-18, 1399/04/28
Registration timing: prospective

Last update: 2020-07-18, 1399/04/28
Update count: 0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Amin Dalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 2557
Email address
daliliam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Ozone Olive Oil on healing of Acute Perianal Fissure
Public title
The Ozone Olive Oil on healing of Acute Perianal Fissure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with acute perianal fissure Age between 18-65 Undergoing medical treatment
Exclusion criteria:
Previous perianal surgery Commodities like Diabetes, IBD, STD, TB Anorectal cancers Immunodeficiency diseases
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be individually randomized using block randomization method in quadruple blocks by randomization.com website. Allocation concealment will be done using sealed, opaque, and sequentially numbered envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Reseacher, Patients, The nurse who collects the data, Data analyser
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ibn-e-Sina St, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.820

Health conditions studied

1

Description of health condition studied
Acute perianal fissure
ICD-10 code
K60.0
ICD-10 code description
Acute anal fissure

Primary outcomes

1

Description
The severity of pain
Timepoint
Weekly follow up till 2 months
Method of measurement
Physical examination by surgeon and VAS score

2

Description
Bleeding
Timepoint
Weekly follow up till 2 months
Method of measurement
Physical examination by surgeon

3

Description
Itching
Timepoint
Weekly follow up till 2 months
Method of measurement
Patient report in VAS scale

4

Description
Wound healing
Timepoint
Weekly follow up till 2 months
Method of measurement
Physical examination by surgeon

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Standard treatment and Ozone olive oil ointment
Category
Treatment - Drugs

2

Description
Control group: Standard treatment (Sitting in warm water, using laxative and stool bulking twice a day with plain olive oil ointment)
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Dalili
Street address
Ibn-e-Sina St, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3852 5255
Email
daliliam@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
009851
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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