The Efficacy of Adding Daflon to the Conventional Treatment on the Improvement of Symptoms and Health-Related Quality of Life in the Patients with Acute Hemorrhoids: A randomized clinical trial
The Efficacy of Adding Daflon to the Conventional Treatment on the Improvement of Symptoms and Health-Related Quality of Life in the Patients with Acute Hemorrhoids
Design
Randomized , parallel clinical trial study
Settings and conduct
Rasoul-e-Akram Hospital
Patients with acute hemorrhoids selected in this study were treated with Daflon (500 mg) three tablets twice daily for the first four days and two pills twice daily for three days afterwards. Patients were followed up by SF-12V1 Health Survey questionnaire (telephone and face-to-face visits) before and after two weeks after treatment in terms of severity of pain and health examination.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The patients with age above 18 years and acute hemorrhoid crisis
Exclusion criteria: The patients with a history of previous anorectal or hemorrhoid surgery, hemorrhoid grade I and IV, lactation, pregnancy, medications such as anti-depressant and flavonoid drugs, severe systemic disease, hypertension, seizure, non-cooperative, cancer, sleep disorders and allergy to daflon.
Intervention groups
Group A; Anti-hemorrhoidal ointment, Seitz bath, and lifestyle modification.
Group B; received three tablets of daflon(500 mg) 1500 mg bid for the first four days and after that two tablets of daflon 1000 mg bid for next three days plus conventional treatment same as the group A.
Main outcome variables
Anal pain score; Bleeding status; SF-12V1 Health Survey Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141201020178N9
Registration date:2019-05-24, 1398/03/03
Registration timing:retrospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Marjan Mokhtare
Name of organization / entity
Iran University of Medical sciences,Rasoul Akram Hospital,Colorectal Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 2845
Email address
mokhtare.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2019-01-19, 1397/10/29
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2019-01-20, 1397/10/30
Trial completion date
2019-02-04, 1397/11/15
Scientific title
The Efficacy of Adding Daflon to the Conventional Treatment on the Improvement of Symptoms and Health-Related Quality of Life in the Patients with Acute Hemorrhoids: A randomized clinical trial
Public title
estimation of the efficacy and adverse effect of daflon when it is added to the conventional treatments in patients with acute hemorrhoids
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age more than 18 years
acute hemorrhoid crisis(anal pain and anal bleeding)
Exclusion criteria:
Grade I and IV of hemorrhoid
previous history of surgery related to the anorectal or hemorrhoid disease
lactation
Patients with the history of other chronic systemic diseases, such as heart, kidney, or liver disease, hypertension, seizure
pregnancy
cancer history
medications such as anti-depressant and flavonoid drugs
non-cooperative
sleep disorders
allergy to daflon
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
individual random table of random numbers generated by the computer softwares
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
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, West Shahid Hemmat Highway,Intersection of Chamran and Sheikh Fazlollah Noori
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-08-23, 1397/06/01
Ethics committee reference number
IR.IUMS.FMD.REC.1397.246
Health conditions studied
1
Description of health condition studied
Acute Hemorrhoidal disease
ICD-10 code
K64
ICD-10 code description
Hemorrhoids and perianal venous thrombosis
Primary outcomes
1
Description
pain score
Timepoint
Before and two weeks after starting treatment
Method of measurement
VAS
2
Description
bleeding
Timepoint
Before and two weeks after starting treatment
Method of measurement
No bleeding / with every defication / daily / weekly / monthly
3
Description
SF-12V1 Health Survey Questionnaire
Timepoint
before and 2 weeks after the starting the treatment
Method of measurement
SF-12V1 questionnaire
Secondary outcomes
1
Description
Patient compliance rate
Timepoint
two weeks after starting treatment
Method of measurement
Data gathering sheet
2
Description
adverse effect rate
Timepoint
2 weeks after the beginning of the treatment
Method of measurement
patients data gathering sheets
Intervention groups
1
Description
Control group: topical anti-Hemorrhoid ointment, Sitz bath and lifestyle modifications
Category
Treatment - Drugs
2
Description
Intervention group; Daflon 1500 mg twice in a day orally in the first four days and 1000 mg twice in a day for three days later, added to the conventional treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Colorectal ResearchCenter ,Rasoul Akram Hospital
Full name of responsible person
Marjan Mokhtare
Street address
Niayesh Street, Sattarkhan Street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Email
marjanmokhtare@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malakouti SK.
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenteroogist and Hepatologist
Street address
Satarkhan Avenue,Niayesh street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
mokhtare.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist and Hepatologist
Street address
Satarkhan Avenue,Niayesh street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
mokhtare.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Marjan Mokhtare
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterologist and Hepatologist
Street address
Satarkhan Avenue,Niayesh street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
mokhtare.m@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD collected for the primary outcome measure only could be shared
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
This is only available for people working in academic institutions and/ or people working in businesses can also apply to receive it.
Under which criteria data/document could be used
People who working in academic institutions
From where data/document is obtainable
Corresponding author email addresses
What processes are involved for a request to access data/document