Comparison the therapeutic effect of traditional preparation compounded from Wallflower and Damask Rose flowers with the therapeutic effect of anti-fissure cream on anal fissure healings in patients having age of 20-50 years.
The aim of this study is to evaluate the therapeutic effect of a traditional medicine containing Wallflower and Damask rose in anal fissure. Patients in the age range of 20 to 50, who have acute anal fissure with approval of a colorectal specialist are included in the study. The main exclusion criteria are other anorectal diseases (ex. fistula or anal cancer and hemorrhoids), pregnancy and lactation. Patients are divided into three groups of 30 patients: traditional medicine group, positive control group with conventional medication and placebo group. The medication in all three groups is taking a topical ointment for two weeks, twice a day, each time 0.5 g and up to 0.5 cm inside the anus .wound healing and pain relief is evaluated according to the specialist examination and results gathered from the checklist.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016121431406N1
Registration date:2017-01-16, 1395/10/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-16, 1395/10/27
Registrant information
Name
Ghazaleh Mosleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3235 5677
Email address
moslehgh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2018-06-22, 1397/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the therapeutic effect of traditional preparation compounded from Wallflower and Damask Rose flowers with the therapeutic effect of anti-fissure cream on anal fissure healings in patients having age of 20-50 years.
Public title
The therapeutic effects of a topical preparation from Wallflower and Damask Rose on anal fissure.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The expert diagnosis af anal fissure; willingness of patient to cooperate in the project; age of 20-50 years; lack of sensitivity to drug ingredients. Exclusion criteria: Crohn's disease; fistula in the anal area; anal cancer; cardiovascular disorders; hemorrhoids; pregnancy and lactation; patients who consume blood pressure drugs; calcium channel blockers or nitrates; patients with a history of chronic headache; renal failure; HIV; tuberculosis; taking drugs such as heparin or aspirin and certain diseases such as thyroid problems.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Committee of Research Ethics, Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-11-27, 1395/09/07
Ethics committee reference number
IR.SUMS.REC.1395.150
Health conditions studied
1
Description of health condition studied
Acute anal fissure
ICD-10 code
K60.0
ICD-10 code description
Acute anal fissure
Primary outcomes
1
Description
local wound healing
Timepoint
Before taking the drug, after a time period of two weeks and 4-6 weeks after drug is used
Method of measurement
visual scales of wounds
2
Description
Pain relief
Timepoint
Before taking the drug, after a time period of two weeks and 4-6 weeks after drug is used
Method of measurement
Quastionary of pain score
Secondary outcomes
1
Description
Improve quality of life
Timepoint
During and after the course of treatment
Method of measurement
quality of life questionnaire
2
Description
internal anal sphincter pressure
Timepoint
after the consumption of cerate
Method of measurement
manometry
Intervention groups
1
Description
Patients with acute anal fissure in positive control group with conventional medication. which is administered as a rectal ointment for two weeks, twice a day, each time a tip of the finger (0.5 g)
Category
Treatment - Drugs
2
Description
Patients with acute anal fissure in traditional drug group (cerate supplies of rose oil and wallflower oil and beeswax) which is administered as a rectal ointment for two weeks, twice a day, each time a tip of the finger (0.5 g)
Category
Treatment - Drugs
3
Description
Patients with acute anal fissure in placebo group: a simple cerate base (cerate of sesame oil and wax) which is administered as a rectal ointment for two weeks, twice a day, each time a tip of the finger (0.5 g).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Faghihi clinic, colo-rectal research center
Full name of responsible person
Dr Seyed Vahid Hosseini
Street address
Colo-rectal research center, number 1 building, Shahid Dr Faghihi hospital, Zand street, Shiraz
City
shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seyed Basir Hashemi, Vice Chancellor of Research
Street address
Vice-Chancellor for Research, 7th floor, Shiraz University of Medical Sciences, next to the Red Crescent center, Zand Blvd., Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Ghazaleh Mosleh
Position
PhD student, traditional pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy
City
Shiraz
Postal code
Phone
+98 71 3235 5677
Fax
Email
moslehgh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Prof. Abdolali Mohagheghzadeh
Position
Prof. in pharmacognosy
Other areas of specialty/work
Street address
Faculty of parmacy, the head of traditional pharmacy department
City
Shiraz
Postal code
Phone
+98 71 3635 0903
Fax
Email
mohaghegh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of pharmacy
Full name of responsible person
Ghazaleh Mosleh
Position
PhD student, traditional pharmacy
Other areas of specialty/work
Street address
Faculty of pharmacy
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)