Determining the effect of doxycycline on oxidative stress biomarkers in ischemic stroke patients: a clinical trial study.
Design
A controlled, parallel-group, double-blind, randomized, phase 1 clinical trial on 24 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
Hamedan Ba'ath Hospital, ischemic stroke patients and the control group are blood sampled one day before starting treatment with doxycycline and 7 days after treatment with doxycycline. will be done. The study will be double-blinded by nurses and patients. The rand function of Excel software will be used for randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Not using any combination with antioxidant effects in the last month
Exclusion criteria:
Drug intolerance and side effects
Intervention groups
In the intervention group, patients will receive 100 mg doxycycline every 12 hours for 7 days in addition to standard treatments. T
Main outcome variables
The level of MDA in the serum of ischemic stroke patients before and after treatment with doxycycline in the intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031921N6
Registration date:2024-02-24, 1402/12/05
Registration timing:prospective
Last update:2024-02-24, 1402/12/05
Update count:0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
homa naderifar
Name of organization / entity
Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 6134
Email address
homa.naderifar@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-29, 1402/12/10
Expected recruitment end date
2025-02-17, 1403/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Doxycycline on biomarkers of oxidative stress in patients with ischemic stroke: a randomized clinical trial study
Public title
Evaluating the effect of Doxycycline on biomarkers of oxidative stress in patients with ischemic stroke: a randomized clinical trial study
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of acute hemispheric ischemic stroke
Focal neurological disorder
MRI and CT radiological findings consistent with the clinical diagnosis of acute hemispheric stroke
Absence of other concurrent inflammatory disease
Exclusion criteria:
Available evidence based on acute or chronic intracerebral hemorrhage and cerebral aneurysm
Drug intolerance and side effects
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients into two control and intervention groups will be done in a random block. So that there will be 2 sheets A and two sheets B in one envelope, and each time by removing one of the sheets, the patient will be placed in the control or intervention group. The removed sheet will not be returned to the envelope until the sheets inside the envelope are exhausted. Randomization of patients in study groups will be done by a nurse who is not part of the research team
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation of patients into two control and intervention groups will be done in a random block. So that there will be 2 sheets A and two sheets B in one envelope, and each time by removing one of the sheets, the patient will be placed in the control or intervention group. The removed sheet will not be returned to the envelope until the sheets inside the envelope are exhausted. Randomization of patients in study groups will be done by a nurse who is not part of the research team
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Hamadan University of Medical Scieneces