Evaluating 5ASA efficacy in treatment of symptomatic hemorrhoid
Design
A randomized clinical trial with control group, with parallel groups, without
blindness that, 100 patients randomly divided into two groups of 50 subjects with block sizes of 4.
Settings and conduct
The study population was patients over the age of 18 who referred to the Babol Spiritual Medical Center. Patients were randomly divided into two groups by computer-generated random number table method. Hemorrhoids and laxative treatment) plus 5-ASA suppository once daily for 2 weeks
Control group: common hemorrhoid treatment (including anti-hemorrhoid ointment and laxative treatment) for 2 weeks
Participants/Inclusion and exclusion criteria
Inclusion criteria: Sigmoidoscopy, Hemorrhoids based on clinical indicators and examination
Exclusion criteria:Hemorrhoids stage 3 and up, Ulcerative proctitis, Pregnancy or breastfeeding, Allergy to salicylates, Liver dysfunction and Renal dysfunction
Intervention groups
intervention group: Common hemorrhoid treatment (including anti-hemorrhoid ointment and laxative treatment) with 5-ASA suppository once a day for 2 weeks
Control group:Common hemorrhoid treatment (including anti-hemorrhoid ointment and laxative treatment) for 2 weeks
Main outcome variables
Bleeding, Pain, Anal burning
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191226045897N2
Registration date:2021-05-03, 1400/02/13
Registration timing:registered_while_recruiting
Last update:2021-05-03, 1400/02/13
Update count:0
Registration date
2021-05-03, 1400/02/13
Registrant information
Name
Seyed Hassan Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 8269
Email address
h.abedi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-29, 1400/02/09
Expected recruitment end date
2021-10-31, 1400/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating 5ASA efficacy in treatment of symptomatic hemorrhoid in non-IBD patients
Public title
Evaluating 5ASA efficacy in treatment of symptomatic hemorrhoid
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sigmoidoscopy
Hemorrhoids based on clinical indicators and examination
Exclusion criteria:
Hemorrhoids stage 3 and up
Ulcerative proctitis
Pregnancy or breastfeeding
Allergy to salicylates
Liver dysfunction
Renal dysfunction
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The patients randomly divided into two groups of 50 subjects with 4 blocks and an allocation ratio of 1: 1.The free website WWW.randomization .com was used to generate the allocation sequence. The obtained sequence is written in separate sheets and placed in sealed envelopes and given to the main researcher for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of Babol University of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUBABOL.REC.1399.306
Health conditions studied
1
Description of health condition studied
hemorrhoids
ICD-10 code
I84.9
ICD-10 code description
Unspecified haemorrhoids without complication
Primary outcomes
1
Description
Bleeding
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
2
Description
Pain
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
3
Description
Anal burning
Timepoint
Before intervention, 2 weeks after the initial intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Common hemorrhoid treatment (including anti-hemorrhoid ointment and laxative treatment) with 5-ASA suppository once a day for 2 weeks
Category
Treatment - Drugs
2
Description
Control group: Common hemorrhoid treatment (including anti-hemorrhoid ointment and laxative treatment) for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
seyed Hassan Abedi
Street address
Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
h.abedi@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice-chancellor Of Research, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?