1. Home
  2. Approved trials
  3. » فارسی

The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study

Protocol summary

Study aim
The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure
Design
Study is a parallel, double-blind, randomized controlled clinical trial. Each group has a sample size of 73 people and the total sample size is 146 people. Patients will be divided into two groups (group one and two) using a simple randomization method.
Settings and conduct
The study will be done in Rafsanjan city's Health Clinic. The physician, outcome evaluator, researchers and patients will be blinded. After diagnosis of the disease by the physician, the patient will be introduced to the data analysis team to be placed in one of two groups and drug will be given to the patients by this team. During the study patients will be visited by physician every 14 days and data will be collected. For assessment of relapse cases, patients also will be visited at the end of the 8th and sixteenth weeks after the end of the intervention.
Participants/Inclusion and exclusion criteria
Participants: Patients with chronic anal fissure who are 18 to 79 years. Inclusion criteria: Patients with pain and bleeding during defecation symptoms which was lasting for at least 8 weeks. exclusion criteria: Patients with other anorectal diseases, irritablebowel disease, patients who have STDs, anorectal neoplasms, anal incontinency and anal surgery, pelvic radiotherapy, patients with chronic anal fissure who are on medical treatment and patients without compliance to medical treatment.
Intervention groups
Group one (Intervention Group) will receive Glyceryl trinitrate 0.2% + Ostrich oil 50% ointment. Group two (control group) will receive 0.2% Glyceryl trinitrate ointment. Patients should apply approximately 2 cm of ointment on outer surface of the anal area every 12 hours.
Main outcome variables
Wound healing, pain, bleeding grading, quality of life, recurrence of the disease

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190128042525N4
Registration date: 2020-11-02, 1399/08/12
Registration timing: registered_while_recruiting

Last update: 2020-11-02, 1399/08/12
Update count: 0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Gholamreza Bazmandegan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0185
Email address
clinical.research@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study
Public title
The effect of ostrich oil on treatment and quality of life of patients with chronic anal fissure: a randomized, double-blind clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with symptoms of the disease such as pain or bleeding during defecation which was lasting for at least 8 weeks. Patients having anorectal region's posterior or anterior wound in examination in lithotomy position, which is associated with skin tag. Also horizontal smooth muscle fibers are visible at the base of the wound and sphincter is hypertrophic.
Exclusion criteria:
Patients with other anorectal diseases such as hemorrhoids, fistulas and abscesses, diabetes, tuberculosis, Crohn's and ulcerative colitis, anorectal neoplasm, leukemia and STDs such as AIDS and syphilis. Patients with history of anal surgery Patients with history of medical treatment of chronic anal fissure Patients who underwent pelvic radiotherapy Patients who are receiving chemotherapy or using immunosuppressive drugs Patients with anal incontinence Patients without medical treatment compliance
Age
From 18 years old to 79 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 146
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups (group one and two) using random numbers' table (simple randomization method).
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blind study. The drugs will be placed in the same and encoded cans, so the patient, doctor and outcome assessor will not be informed about type of prescribed drug. Coding won't be done by principal investigator and won't have access to the coding informations.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of rafsanjan University of Medical Sciences
Street address
َAli Ibn Abi-talib Square
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Approval date
2020-10-04, 1399/07/13
Ethics committee reference number
IR.RUMS.REC.1399.162

Health conditions studied

1

Description of health condition studied
chronic anal fissure
ICD-10 code
K60.1
ICD-10 code description
Chronic anal fissure

Primary outcomes

1

Description
pain scoring
Timepoint
Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention.
Method of measurement
Visual Analogue Scale Questionnaire

2

Description
Wound grading
Timepoint
Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention.
Method of measurement
By means of physical examination and grading: grade I (fresh wound with inflammation), grade II (wound with granulation tissue) and grade III (wound covered with complete epithelial tissue)

3

Description
Bleeding grading
Timepoint
Once before starting the intervention then every 14 days after starting the intervention and twice at the end of 8th & 16th weeks after intervention.
Method of measurement
By means of history taking : grade I (there is no bleeding during defecation), grade II (sometimes there is bleeding during defecation) and grade III (there is always bleeding during defecation)

Secondary outcomes

1

Description
Quality of life score
Timepoint
After complete recovery of the patient and cessation of treatment
Method of measurement
Completing the World Health Organization's (26-Question) Quality of Life Questionnaire

2

Description
Recurrence of the disease
Timepoint
At the end of 8th & 16th weeks of follow up period
Method of measurement
By history taking and physical examination

Intervention groups

1

Description
Intervention group: 100 g container contained Glyceryl trinitrate 0.2% -Ostrich oil 50% ointment will be prescribed for the patients. These drugs will be manufactured by Pasargad Rafsanjan Pharmacy. For their formulation 60 ml ostrich oil containers from Iranian cooperative Kesht Va Sanat Misagh, Kesht Ati company under the brand name Mika will be purchased. After making drugs patients will apply approximately 2 cm of it, topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks.
Category
Treatment - Drugs

2

Description
Control group: 100 g container concluded 0.2% Glyceryl trinitrate ointment will be prescribed. approximately 2 cm of it will be applied topically on the anal area every 12 hours. The maximum treatment period will be 12 weeks. The container ingredients will be produced by Pasargad Pharmacy in Rafsanjan.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rafsanjan Health clinic
Full name of responsible person
Masoumeh Taghizadeh
Street address
Rafsanjan Health clinic, Persian Gulf Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
Clinical.research@rums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Rafsanjan University of Medical Sciences
Street address
Ali-Ibn Abi-Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoumeh Taghizadeh
Position
Assistan professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn Abi-Talib Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoumeh Taghizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn Abi-Talib Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Masoumeh Taghizadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ibn Abi-Talib Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Fax
+98 34 3428 0185
Email
clinical.research@rums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...