Determining the effect of saffron extract on the level of consciousness, cognitive function, and serum antioxidant capacity in patients with traumatic brain injury: A double-blind controlled randomized clinical trial
Determining the effect of Saffron Extract on the level of consciousness, cognitive function and serum antioxidant capacity in patients with traumatic brain injury
Design
This study is a double-blind controlled randomized clinical trial that is conducted in parallel mode. The number of samples was calculated at 21 people in each group.
Settings and conduct
The research setting is the Intensive Care Unit and Neurosurgery Center of Imam Hossein Hospital affiliated with Torbat-e-Heydariyeh University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hospitalization for fewer than 3 days, age range between 18 and 65 years, patients with mild to moderate traumatic brain injury based on GCS index (9-15),
no record of delirium, dementia, and hospitalization in psychiatric hospitals or centers,
There is no record of active bleeding or coagulation disorders or allergies to saffron.
Exclusion criteria: Children and elderly with traumatic brain injury, patients with severe traumatic brain injury, any record of non-traumatic cerebral hemorrhage, and
decreased level of consciousness due to metabolic disorders.
Intervention groups
Patients in the first intervention group are given saffron hydroalcoholic extract syrup (100 mg per day) for 10 days.
Patients in the second intervention group receive a hydroalcoholic extract of saffron along with rose water and sugar, at a dose of 100 milligrams of saffron per day, for 10 days.
Main outcome variables
Consciousness level and cognitive function of patients with traumatic brain injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131204015649N5
Registration date:2023-05-18, 1402/02/28
Registration timing:prospective
Last update:2023-05-18, 1402/02/28
Update count:1
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Mohammad Eghbali
Name of organization / entity
Torbat Heydariyeh University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 5242 1257
Email address
m-eghbali@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effect of saffron extract on the level of consciousness, cognitive function, and serum antioxidant capacity in patients with traumatic brain injury: A double-blind controlled randomized clinical trial
Public title
Effectiveness of saffron extract on the level of consciousness, cognitive function, and serum antioxidant capacity in patients with traumatic brain injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization for fewer than 3 days
Age range between 18 and 65 years
Patients with mild to moderate traumatic brain injury based on GCS index (9-15)
No record of delirium, dementia, and hospitalization in psychiatric hospitals or centers
No record of active bleeding or coagulation disorders,
No record of allergies to saffron.
Exclusion criteria:
Children and elderly with traumatic brain injury
Patients with severe traumatic brain injury
Any record of non-traumatic cerebral hemorrhage
Decreased level of consciousness due to metabolic disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block design (based on triple block size) was used for randomization. The random sequence was proposed by a statistical expert; then, appropriate software was employed accordingly. Overall, 21 blocks of three were prepared, and then the samples were assigned to three groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the corresponding researcher produces syrups containing saffron extract and identical placebo in similar cans. These cans are labeled as 1, 2, and 3. Thus, none of the participants, university researchers, hospital personnel, data collectors, or data analysts was informed whether the cans contain saffron or the placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Medicine- Tehran University of Medical Sciences
Street address
Secretariat of Ethics Committee in Biomedical Research, University of Tehran, Keshavarz Blvd., Intersection of Quds St., Central Building, Tehran University of Medical Sciences, 6th Floor
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.036
Health conditions studied
1
Description of health condition studied
Patients with traumatic brain injury
ICD-10 code
S06.9
ICD-10 code description
Unspecified intracranial injury
Primary outcomes
1
Description
Level of consciousness
Timepoint
Daily for 10 consecutive days
Method of measurement
Glasgow Coma Scale
2
Description
Cognitive Function
Timepoint
Daily for 10 consecutive days
Method of measurement
Rancho Los Amigos Level of Cognitive Functioning Scale
Secondary outcomes
1
Description
Total activities of serum antioxidant
Timepoint
Before the intervention and after 10 days
Method of measurement
The superoxide dismutase (SOD) serum activity was measured based on controlling the reduction of nitro-blue tetrazolium by the superoxide at 560 nm. The catalase (CAT) activity was determined by monitoring the initial rate of disappearance of H2O2 at 240 nm. Glutathione S-transferase (GST) activity was assayed based on monitoring the formation of the thioether product of the reaction between glutathione (GSH) and 1-chloro-2, 4-dinitrobenzene at 340 nm. GSH level was performed at 412 nm by the use of 5, 5’-dithiobis 2-nitrobenzoic acid. Serum glutathione peroxidase (GPx) and glutathione reductase (GR) activities were determined based on the decrease in absorbance of NADPH at 340 nm. The total antioxidant capacity (TAC) was measured by ferric reducing/antioxidant power (FRAP) method using commercially available kit. Malondialdehyde (MDA) level, as an indicator of lipid peroxidation, was measured as a result of condensation with thiobarbituric acid at 532 nm.
Intervention groups
1
Description
Patients in the first intervention group are given saffron hydroalcoholic extract syrup (100 mg per day) for 10 days.This product will be produced by the School of Persian Medicine, Department of Traditional Pharmacy.
Category
Treatment - Other
2
Description
Patients in the second intervention group receive a hydroalcoholic extract of saffron along with rose water and sugar, at a dose of 100 milligrams of saffron per day, for 10 days. This product will be produced by the School of Persian Medicine, Department of Traditional Pharmacy.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive Care Unit and Neurosurgery departments of Imam Hossein hospital
Full name of responsible person
Mohammad Eghbali
Street address
Torbat-e Heydarieh, 5 km from Torbat Heydarieh to Mashhad, Imam Hossein Hospital
City
Torbat-e Heydarieh
Province
Razavi Khorasan
Postal code
9519140001
Phone
+98 51 5242 0000
Fax
+98 51 5242 0244
Email
Eghbali.msn@gmail.com
Web page address
https://ihh.thums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
دکتر اکبر فتوحی
Street address
6th floor, central building of Tehran University of Medical Sciences, Qods St., Keshavarz St., Tehran
City
Tehtan
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3658
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Mohammad Eghbali
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Razi St, Torbat-e-Heydariyeh University of Medical Sciences, Torbat-e-Heydariyeh
City
Torbat-e Heydariyeh
Province
Razavi Khorasan
Postal code
9619633787
Phone
+98 51 5222 9202
Email
eghbali.msn@gmail.com
Web page address
https://snm.thums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Position
Professor of Traditional Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 67, corner of West Jamali Alley, Vafamanesh Street, Heravi Square
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Fax
+98 21 8899 1829
Email
rojarahimi@gmail.com
Web page address
http://spm.tums.ac.ir/contact-us.html
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roja Rahimi
Position
Professor of Traditional Pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No. 67, Harvi Square, vafamanesh Street, corner of West Jamali Street
City
Tehran
Province
Tehran
Postal code
1416663361
Phone
+98 21 8897 4535
Email
rojarahimi@gmail.com
Web page address
http://spm.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Currently, no decision has been made in this regard by the team