Evaluation and comparison of the effect of topical sildenafil and diltiazem gel in the treatment of anal fissure
Design
The study consisted of two groups receiving sildenafil topical cream and diltiazem gel. The sample size is 50 people and each study group includes 25 people. Simple randomization method and Random.org site have been used for randomization.
Settings and conduct
This study will perform in Khatam Al-Anbia Clinic of Yazd University of Medical Sciences. Fifty patients with anal fissure randomly entered into one of two study groups to receive one of the drug groups (sildenafil topical cream 10% and diltiazem gel 2%). Patient evaluating outcome and clinical caregivers from The type of drug was unknown. Information about the onset of analgesic effect and maximum analgesic effect will recorded and collect after drug administration.
Participants/Inclusion and exclusion criteria
Age 18 to 65 years as well as pain after defecation and bleeding are the conditions for inclusion in the study. Exclusion criteria are Lack of fissure pain in an unusual position and recurrent fissure
Intervention groups
Intervention group: sildenafil topical cream 10% was administered intra rectally 3 times daily for one week by the patient.Made in Yazd University of Medical Sciences.
Intervention group: diltiazem gel 2% was used intra rectally 3 times daily for one week by the patient.Prepared in Sobhan Pharmaceutical Company
Main outcome variables
onset of action and decrease pain score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N7
Registration date:2022-05-07, 1401/02/17
Registration timing:registered_while_recruiting
Last update:2022-05-07, 1401/02/17
Update count:0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and comparison of the effect of sildenafil topical cream 10% and diltiazem gel 2%in the treatment of anal fissure
Public title
Evaluation of the effect of topical sildenafil and diltiazem gel in the treatment of fissures
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years
Having symptoms includes pain after defecation bleeding or both
Exclusion criteria:
Recurrent fissure
Fissures in an unusual position
No pain
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple random method was used.Patients were divided into two treatment groups using random numbers generated by Random.org
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, patients, clinical caregivers, and outcome evaluators were not aware of the type of medication patients received.Patients in both groups received drugs in the same package.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd university of medical sciences
Street address
Shahid Sadoughi University of medical sciences Shohadaye Gomnam Blve Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.SSU.MEDICINE.REC.1398.45
Health conditions studied
1
Description of health condition studied
Anal fissure
ICD-10 code
K60.2
ICD-10 code description
Anal fissure, unspecified
Primary outcomes
1
Description
onset of pain reduction
Timepoint
This variable was measured after each use of the drug by the patient.
Method of measurement
Based on questions from the patient
2
Description
Maximum relaxation time
Timepoint
This variable was measured after each use of the drug by the patient.
Method of measurement
Visual Analogue Scale
3
Description
Duration of treatment
Timepoint
After complete consumption of the drug by the patient and complete recovery
Method of measurement
Based on questions from the patient
4
Description
The length of the recovery period
Timepoint
After taking the drug by the patient and that the patient notices a reduction in symptoms after a few days.
Method of measurement
Based on questions from the patient
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : Sildenafil topical cream receives 10% 3 times a day for a week intra-anal patient Made in Yazd University of Medical Sciences
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: The patient received diltiazem gel 2% 3 times a day for one week intra rectally.Made in Sobhan Pharmaceutical Company