Protocol summary
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Study aim
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Determining the effect of Saffron Extract on the level of consciousness, cognitive function and serum antioxidant capacity in patients with traumatic brain injury
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Design
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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.
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Settings and conduct
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The research setting is the Intensive Care Unit and Neurosurgery Center of Imam Reza Hospital affiliated with Tabriz University of Medical Sciences.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Hospitalization for fewer than 3 days, age range between 18 and 65 years, patients with moderate to sever 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.
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Intervention groups
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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.
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Main outcome variables
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Consciousness level and cognitive function of patients with traumatic brain injury
General information
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Reason for update
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Because patients with mild traumatic brain injury have a short hospital stay and it was not possible to perform the intervention for 10 days, these patients were excluded from the inclusion criteria of the study and patients with moderate to severe injury according to the Glasgow Coma Scale (GCS = 3-12) were included in the study. Also, due to the low prevalence of patients with traumatic brain injury in Torbat Heydariyeh, the location of the study was changed to Tabriz due to the larger number of patients and greater cooperation in the research environment.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20131204015649N5
Registration date:
2023-05-18, 1402/02/28
Registration timing:
prospective
Last update:
2025-09-05, 1404/06/14
Update count:
1
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Registration date
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2023-05-18, 1402/02/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-02-01, 1402/11/12
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Expected recruitment end date
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2024-11-01, 1403/08/11
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Actual recruitment start date
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2024-02-01, 1402/11/12
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Actual recruitment end date
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2024-11-01, 1403/08/11
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Trial completion date
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2025-11-22, 1404/09/01
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Scientific title
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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
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Public title
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Effectiveness of saffron extract on the level of consciousness, cognitive function, and serum antioxidant capacity in patients with traumatic brain injury
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Hospitalization for fewer than 3 days
Age range between 18 and 65 years
Patients with moderate to sever traumatic brain injury based on GCS index (3-12)
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
63
Actual sample size reached:
63
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-04-11, 1402/01/22
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1402.036
Health conditions studied
1
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Description of health condition studied
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Patients with traumatic brain injury
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ICD-10 code
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S06.9
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ICD-10 code description
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Unspecified intracranial injury
Primary outcomes
1
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Description
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Level of consciousness
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Timepoint
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Daily for 10 consecutive days
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Method of measurement
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Glasgow Coma Scale
2
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Description
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Cognitive Function
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Timepoint
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Daily for 10 consecutive days
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Method of measurement
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Rancho Los Amigos Level of Cognitive Functioning Scale
Secondary outcomes
1
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Description
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Total activities of serum antioxidant
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Timepoint
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Before the intervention and after 10 days
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Method of measurement
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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
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Currently, no decision has been made in this regard by the team
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available