Determining the effect of saffron medicine on prognosis in patients with ischemic stroke for timely treatment and reducing side effects caused by stroke.
Design
A clinical trial with a control group, with parallel groups. No blinding. Phase 3 was randomized on 72 patients and a balanced block was used for randomization
Settings and conduct
It is an intervention and randomized controlled clinical trial study. The sample size is 72 people. Patients with acute cerebral stroke in the special care department of Shahid Beheshti Hospital, Qom and after obtaining written consent, were divided into two groups by randomization using the block randomization method: The first group includes 37 patients who, in addition to the usual treatment in the intensive care unit, will receive 30 mg of saffron capsules daily (15 mg twice a day) for 30 days.
The second group of 37 patients will receive only routine care
Participants/Inclusion and exclusion criteria
Inclusion: Age over 18 years - GCS less than equal to ten
Patients without coagulation disorders and absence of coagulation or platelet disorders at the time of admission
NIHSS less than 15, Not allergic to saffron؛
Exclusion:
Liver disorder, kidney disorder, fever, convulsions
Intervention groups
Intervention group: including 37 patients who will receive 30 mg of saffron capsules (15 mg twice a day) for 30 days in addition to the usual treatment in the intensive care unit.
Control group: 37 patients who will receive only usual care
Main outcome variables
level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230715058781N1
Registration date:2023-07-17, 1402/04/26
Registration timing:prospective
Last update:2023-07-17, 1402/04/26
Update count:0
Registration date
2023-07-17, 1402/04/26
Registrant information
Name
somayeh mehrpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2000
Email address
somayeh.mehrpour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of saffron medicine on the prognosis of ischemic CVA patients with NIHSS less than 15
Public title
Investigating the effect of saffron on the consciousness of stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ischemic stroke
Exclusion criteria:
Coagulation disorders
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com). Allocation concealment is also guaranteed due to the use of special codes generated by the website
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
Research Ethics Committees of Qom University of Medical Sciences
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3719964797
Approval date
2023-05-15, 1402/02/25
Ethics committee reference number
IR.MUQ.REC.1402.074
Health conditions studied
1
Description of health condition studied
cerebrovascular accident
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
level of consciousness
Timepoint
arrival; hospitalization time; while receiving medication
Method of measurement
Glasgow coma scale
Secondary outcomes
1
Description
Length of hospitalization
Timepoint
The time of the patient's discharge from the hospital
Method of measurement
National Institutes Of Health Stroke Scale
Intervention groups
1
Description
Intervention group: Including 37 patients who will receive 30 mg of saffron capsules from Duralife -Faran Chemi Pharmaceutical Company (15 mg twice a day) for 30 days orally in addition to the usual treatment(including anti platelet, statin, blood sugar and blood pressure control) in the intensive care unit.
Category
Treatment - Drugs
2
Description
Control group: 37 patients who will receive only routine care(including anti platelet, statin, blood sugar, and blood pressure control.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Somayeh Mehrpour
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
37719964797
Phone
+98 25 3612 2000
Email
somayeh.mehrpour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Rahim Aali
Street address
No. 83, Shahid Lotfi Niaser Ave, Safashehr Blvd
City
Qom
Province
Ghoum
Postal code
3716993456
Phone
+98 25 3285 4011
Email
rahimalii@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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
Ghoum University of Medical Sciences
Full name of responsible person
Somayeh Mehrpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital
City
QOM
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
Email
somayeh.mehrpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Somayeh Mehrpour
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital
City
QOM
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Fax
Email
somayeh.mehrpour@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Somayeh Mehrpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Beheshti Hospital, Beheshti Blvd, Qom, Iran
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2000
Email
somayeh.mehrpour@gmail.com
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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available