The determination of effects of Daflon tablet on symptoms of hemorrhoids, its relapse and patients' duration of hospitalization
Design
Double-blinded, randomized, parallel clinical trial with a sample size of 200 patients; 100 patients in Daflon group and 100 patients in placebo group.
Settings and conduct
Participants are randomly selected from patients who are diagnosed by grade 3 or 4 of hemorrhoids in Shahid Madani surgery clinic in 2021 to 2022.
After inclusion patients are allocated in to Daflon and placebo group. They will undergo treatment for 4 weeks.
Eventually, patients are going to get assessed in terms of duration, severity and relapse of patients' signs and symptoms.
Participants/Inclusion and exclusion criteria
Patients over the age of 18 years old who were diagnosed with grade 3 or 4 of hemorrhoids based on a surgeons' physical exam and history taking are going to be included in the study.
Patients who have history of previous treatment of hemorrhoids, consumption or allergy to Daflon tablet, renal failure or electrolytes imbalance, serious underlying disease, including immunodeficiency disease, hyperparathyroidism, complete heart block, addison's disease, intestinal disorders, or malignancies are going to get excluded from the study.
Intervention groups
Case group: 100 patients are going to receive Daflon 500mg tablet each 12 hours for 4 weeks.
Control group: 100 patients are going to receive placebo each 12 hours for 4 weeks.
Main outcome variables
Duration of improvement in sign and symptoms; severity of symptoms; relapse of symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210625051698N1
Registration date:2021-07-06, 1400/04/15
Registration timing:prospective
Last update:2021-07-06, 1400/04/15
Update count:0
Registration date
2021-07-06, 1400/04/15
Registrant information
Name
Mohsen Karimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3255 8080
Email address
mohsenkarimian494@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-01-13, 1400/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of effects of Daflon tablet on symptoms of hemorrhoids, its relapse and patients' duration of hospitalization
Public title
The evaluation of effects of Daflon tablet on hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over the age of 18 years old who were diagnosed with grade 3 or 4 of hemorrhoids based on a surgeons' physical exam and history taking
Exclusion criteria:
Does not have a history of previous treatment of hemorrhoids.
Does not have a history of consumption or allergy to Daflon tablet.
Does not have a history of renal failure or electrolytes imbalance.
Does not have a serious underlying disease, including immunodeficiency disease, hyperparathyroidism, complete heart block, addison's disease, intestinal disorders, or malignancies.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated into the intervention and control groups using permuted balance block randomization. The blocks are four. Using STATA software, random numbers are generated from 1 to 6. Another number is generated when the previous number is more than 6, without considering it. An individual who is not participated in design and conduction of study prepares the random numbers and put them in pockets with a five-digit serial number. All pockets with 5 digit numbers open after including a patient, and the patient is allocated to one of the two groups. In the case group patients are given Daflon 500mg per 12 hours for 4 weeks. In contrast, the control group patients are given placebo per 12 hours for 4 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
in this double blind study patients are not going to be aware of whether they have given placebo or Daflon. Moreover, the clinicians are not going to be aware of patients allocation.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Alborz University of Medical Sciences
Street address
Deputy of research, Alborz university of medical sciences, Safarian street, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Approval date
2021-05-16, 1400/02/26
Ethics committee reference number
IR.ABZUMS.REC.1400.072
Health conditions studied
1
Description of health condition studied
Hemorrhoids
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
Duration of improvements of sign and symptoms
Timepoint
4 weeks after inclusion
Method of measurement
Duration of times that takes for patients for their signs to get improved.
2
Description
Severity of sign and symptoms
Timepoint
4 weeks after inclusion
Method of measurement
The severity of symptoms are going to get reported by patients 4 weeks after inclusion based on visual Analogue scale.
3
Description
Relapse of sign and symptoms
Timepoint
4 weeks after inclusion
Method of measurement
In case of resolution of symptoms in 4 weeks, patients report relapse of their symptoms.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Daflon group: After inclusion patients consume Daflon 500mg, which is produced Amin pharmaceutical company and comprise flavonoid agents by tablet each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ).
Category
Treatment - Drugs
2
Description
Control group: Placebo group: Patients consume placebo, which is similar to Daflon in terms of taste and appearance each 12 hours (every day, twice a day) for 4 weeks (each participant consume 56 pills during the trial ).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Mohsen Karimian
Street address
Shahid madani hospital, Jahanshar
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
research@abzums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohammad Noorisepehr
Street address
Deputy of research, Alborz university of medical sciences, Safarian street, Golshahr
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3464 3705
Email
research@abzums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Karaj 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
Karaj University of Medical Sciences
Full name of responsible person
Mohsen Karimian
Position
Residens
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 14 golestan3 ave , azimiye blvd,karaj town
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3255 8080
Fax
Email
Mohsenkarimian494@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohsen Karimian
Position
Residens
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 14 golestan3 ave , azimiye blvd,karaj town
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3255 8080
Fax
Email
Mohsenkarimian494@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Karaj University of Medical Sciences
Full name of responsible person
Mohsen Karimian
Position
Residens
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No 14 golestan3 ave , azimiye blvd,karaj town
City
Karaj
Province
Alborz
Postal code
3198764653
Phone
+98 26 3255 8080
Fax
Email
Mohsenkarimian494@gmail.com
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