Determining and comparing the effect of daflon and pentoxifylline on the clinical symptoms of chronic venous insufficiency
Design
Each patient will enter the study after checking the conditions of entering the study and obtaining informed consent. Allocating the samples to the groups will be done with a table of random numbers. After the initial diagnosis by the vascular surgeon, the patients are referred to the student administrator for grouping and randomization, and the student does not know the type of treatment of the patients.
Settings and conduct
All patients have medical records and are visited every two months. Patients who do not complete the treatment or do not return will be excluded from the study.
According to the number of prescription drugs and bimonthly visits, the compliance rate of patients is evaluated. Full compliance with the prescription is essential.
The change in the patient's symptoms and vcss score following the intervention is the outcome of the study.
The initial, serial and final examinations of the patient are performed by the vascular surgeon and the patients' information is recorded.
Participants/Inclusion and exclusion criteria
-Chronic venous insufficiency disease with class C2 and more
- Ability to communicate
- Not having a history of psychiatric illness
Consent to take medicine
Intervention groups
The study will be completed by a clinical trial method with a sample size of 100 people in two groups of 50 people by patients who will refer to the vascular surgery center due to chronic venous insufficiency.
The first group takes pentoxifylline 400 mg every 8 hours and the second group takes Daflon 500 mg every 12 hours for 6 months.
Main outcome variables
increase in venous tone; suppression of inflammatory reactions; significant reduction in leg size; improving patient performance; Reduce limb pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221213056808N1
Registration date:2023-04-17, 1402/01/28
Registration timing:registered_while_recruiting
Last update:2023-04-17, 1402/01/28
Update count:0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
Iman Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3252 7741
Email address
imanheidari72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigation and Comparison of the effect of Daflon and pentoxifylline in the treatment of patients with chronic venous insufficiency
Public title
investigation and Comparison of the effect of Daflon and pentoxifylline in the treatment of patients with chronic venous insufficiency
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Chronic venous insufficiency disease with class C2 and more according to CEAP criteria
Consent to take medicine
Ability to communicate
Exclusion criteria:
Patients who are candidates for surgery
Patients who do not take medicine
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples to groups will be done with a table of random numbers. In this way, the substitutions of ABC-ACB-BAC-BCA-CAB-CBA and assigning code 1 to 6 will be done. In the table of random numbers, a single-digit number will be randomly selected and moved down, and with each number obtained, the corresponding place of those samples will be assigned to groups. If the numbers zero, 7, 8 and 9 are obtained, they will not be considered.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not know their allocation to study groups. Allocation of the samples to the studied groups will be done by the respected vascular surgeon and based on the table of random numbers, and the student will not know about it either.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
5 Azar Street, 5 Azar Hospital, Surgery Department
City
Gorgan
Province
Golestan
Postal code
4917761551
Approval date
2023-01-01, 1401/10/11
Ethics committee reference number
IR.GOUMS.REC.1401.480
Health conditions studied
1
Description of health condition studied
Patients with chronic venous insufficiency
ICD-10 code
I87.2
ICD-10 code description
Venous insufficiency (chronic) (peripheral)
Primary outcomes
1
Description
CEAP( classification stands for Clinical (C), Etiological (E), Anatomical (A), and Pathophysiological (P)) Score
Timepoint
At the beginning of the study and 6 months after taking the drug
Method of measurement
C0: no obvious features of the disease: C1: spider veins C2: obvious varicose veins: C3: edema: C4: eczema and skin discoloration: C5: healing wounds C6: active wounds with exudation
2
Description
Venous Clinical Severity Score(vcss score)
Timepoint
At the beginning of the study and 6 months after taking the drug
The first intervention group: patients who entered the study according to the inclusion criteria and were treated with pentoxifylline tablets (from Farabi company) at a dose of 400 mg three times a day for 6 months.
Category
Treatment - Drugs
2
Description
The second intervention group: patients who entered the study according to the inclusion criteria and were treated with Daflon tablets 500 mg twice a day for 6 months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
5 Azar hospital
Full name of responsible person
Iman Heidari
Street address
5 Azar St
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3222 0561
Email
pr-5azar@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Research and Technology Vice-Chancellor,2nd Floor,Central Library Building,Higher Philosophical Education Complex,Shasat Kala Road,gorgan
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 1660
Email
n.mirbehbahani@gmail.com
Web page address
https://goums.ac.ir/index.php?slc_lang=fa&sid=12
Grant name
.
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Iman Heidari
Position
General surgery assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Farhang building ; Edalat 61 ; Naharkhoran Boulevard
City
Gorgan
Province
Golestan
Postal code
4917845653
Phone
+98 17 3252 7741
Email
Imanheidari72@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Pezhman Kharazm
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Vascular Surgery
Street address
Surgery Department Office ;Shahid Nabawi Building; fifth floor; 5 Azar Hospital
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
0098 17 3153366
Email
Pezhmankh@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Iman Heidari
Position
General Surgery Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Farhang building ; Edalat 61 ; Naharkhoran Boulevard
City
Gorgan
Province
Golestan
Postal code
4917845653
Phone
+98 17 3252 7741
Email
Imanheidari72@gmail.com
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
After conducting a study on patients who have taken two drugs, Daflon and Pentoxifylline, for a certain period of time, all the classified data can be shared after de-identifying the patients.
When the data will become available and for how long
The access period starts 1 month after the results are published
To whom data/document is available
The data will be available to all researchers working in academic and scientific institutions as well as people working in the industry.
Under which criteria data/document could be used
There is no specific limitation.
From where data/document is obtainable
Dr Iman Heidari
mobile:09113222421
email: imanheidari72@gmail.com
What processes are involved for a request to access data/document
The reason for the request regarding the data and the subject of study should be emailed to the desired address, as soon as it is reviewed, it will be provided to the requester in the shortest possible time.