To assess the effect of doxycycline versus placebo on clinical outcomes in patients with ischemic stroke
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Besat Hospital in Hamadan city on 70 eligible patients. The patients with ischemic stroke will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double -blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 85 years
Ischemic stroke in the last 24 hours
Exclusion criteria:
Pregnancy and lactation
History of ischemic stroke
Intervention groups
Intervention group:
Routine treatment plus doxycycline capsule 100 mg every 12 hours for 7 days
Control group:
Routine treatment plus placebo starch) capsule every 12 hours for 7 days
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of doxycycline versus placebo on clinical outcomes in patients with ischemic stroke: a double-blind randomized clinical trial
Public title
Effect of doxycycline versus placebo on clinical outcomes in patients with ischemic stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 85 years
Ischemic stroke in the last 24 hours
Exclusion criteria:
Pregnancy or lactation
History of ischemic stroke
Age
From 18 years old to 85 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-06-25, 1401/04/04
Ethics committee reference number
IR.UMSHA.REC.1401.317
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Neurological dysfunction
Timepoint
Before intervention, one week, one and three months later
Method of measurement
Using the NIH Stroke Scale (NIHSS)
2
Description
Functional dysfunction
Timepoint
Before intervention, one week, one and three months later
Method of measurement
Using the modified Rankin Scale (mRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment plus doxycycline capsule 100 mg every 12 hours for 7 days
Category
Treatment - Drugs
2
Description
Control group: Routine treatment plus placebo starch) capsule every 12 hours for 7 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital in Hamadan city
Full name of responsible person
Zahra Aminian
Street address
Besat Hospital, Shahed Square
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Email
zahra.amn95@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Zahra Aminian
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
00989182055594
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahra.amn95@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mojtaba Khazaei
Position
Neurologist
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khazaeimojtaba@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Medical doctor
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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