Evaluation of the effect of resveratrol on the outcome of patients with acute stroke who received r-tPA.
Design
A randomized controlled clinical trial with parallel, double-blind, randomized groups
Settings and conduct
This study is conducted at Imam Reza Hospital in Kermanshah. The research area is related to stroke and is done by block randomization method with a block size of 4 which is detailed in the previous section. After random selection of participants (patients), in order to secrete (hide) the given treatment type from groups, the studied drugs will be made identical in appearance (1st level of blinding), and for blinding the doctor, the drugs are prepacked in packets marked as packet A and B. Then in the final step, depending on the assigned code (A or B) given to the patient, the related treatment will be given to the participant.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patient satisfaction and patient companions who received r-tPA.
Exclusion criteria include pregnant patients or people under 18 and over 90 years or patients who have received r-tPA for more than 24 hours.
Intervention groups
Intervention group: Resveratrol
control group: placebo
Main outcome variables
Reduction of bleeding caused by clotting agent as well as beneficial effects in the treatment of stroke
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191020045162N1
Registration date:2020-03-12, 1398/12/22
Registration timing:registered_while_recruiting
Last update:2020-03-12, 1398/12/22
Update count:0
Registration date
2020-03-12, 1398/12/22
Registrant information
Name
Dalir Parsa
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6321
Email address
drdparsa68@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2021-01-09, 1399/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of resveratrol on therapeutic outcomes of acute ischemic stroke patient receiving r-tPA
Public title
The effect of resveratrol on stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
َAll of acute ischemic stroke patient reciving r-tPA.
Exclusion criteria:
Pregnant patient
Patients who received r-tPA more than 24 hours ago
Previous cerebral hemorrhage and previous stroke
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used since patients go to the doctors over time, and we aim to have both studied groups receive equal treatment. To do so, we use a block size of 4 and for the sample size of 40 a block size of 4 will be generated. Then, in the next step, beside block randomization, each generated random sequence will be written on a separate card and placed in non-transparent blocks, like block number 1 sequence AABB. They are used based on numerical orders allocated to each block, and block sequence for the studied patients is used. This procedure will be carried out till the end of the study. In order to use the random allocation method, a methodologist places the blocks in sequence, handles the blocking and numbering process according to the required sample size, and shares them with the related department’s receptionist who is not aware of the studied treatments. Then he/she informs the patients the purpose of this study and investigates the input and output criteria of the study. In the final step, the patients will be assigned to the related studied group by receiving a code from the receptionist and will be referred to a doctor.
Blinding (investigator's opinion)
Double blinded
Blinding description
After a random selection of patients To hide groups receiving treatment, the capsule understudy will be similar in shape (First level blinding) and to blind the therapist, Drugs are prepackaged in envelopes marked A and B and depending on which code the patient goes to see a doctor will receive the desired treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kermanshah university of medical siences
Street address
Nursing Blvd - Imam reza hospital
City
kermanshah
Province
Kermanshah
Postal code
6714415333
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.KUMS.REC.1398.718
Health conditions studied
1
Description of health condition studied
Ischemic stroke
ICD-10 code
I67
ICD-10 code description
Other cerebrovascular diseases
Primary outcomes
1
Description
NIHSS : National Institutes of Health Stroke Scale
Timepoint
Symptoms onset - 24 hours later - discharge time
Method of measurement
Using a checklist and a special form that will be filled in according to the patient's history and examination.
2
Description
Modified Rankin Scale (MRS)
Timepoint
Before symptoms begin - three months later
Method of measurement
Based on specific forms that the patient or his / her companions will be asked to telephone or in person.
3
Description
Barthel Index
Timepoint
Three months later
Method of measurement
Based on specific forms that the patient or his / her companions will be asked by phone or in person.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with stroke receiving r-tPA who receive oral resveratrol capsule (150 mg every eight hours) and herbal medicine purchased from overseas and Packaged by pharmacists at Kermanshah School of Pharmacy.
Category
Treatment - Drugs
2
Description
Control group: Patients with stroke receiving r-tPA who receive placebo(Lactulose oral capsule every eight hours) and Packaged by pharmacists at Kermanshah School of Pharmacy.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Payam Sari aslani
Street address
Parastar blv - Imam reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6303
Email
drdparsa68@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Payam Sari aslani
Street address
Parastar blvd - Imam reza hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6303
Email
drdparsa68@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Payam Sariaslani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Parsatar Blvd, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6303
Email
drdparsa68@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Payam Sariaslani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Parsatar Blvd, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6303
Email
drdparsa68@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Payam Sariaslani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Parastar Blvd, Imam Reza Hospital
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6303
Email
drdparsa68@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
The amount of changes in MRS and Bartel index in the two groups
When the data will become available and for how long
6 month after publishing article
To whom data/document is available
For the public
Under which criteria data/document could be used
For further research
From where data/document is obtainable
Imam Reza Hospital Kermanshah - Dr. Payam Sariaslani
What processes are involved for a request to access data/document
Applying to the hospital and Dr. Sariaslani will then announce the outcome.