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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131204015649N5
Enrollment
63
Registered
2023-05-18
Start date
2024-02-01
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with traumatic brain injury. Unspecified intracranial injury

Interventions

Intervention 1: 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, De

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Level of consciousness. Timepoint: Daily for 10 consecutive days. Method of measurement: Glasgow Coma Scale.;Cognitive Function. Timepoint: Daily for 10 consecutive days. Method of measurement: Rancho Los Amigos Level of Cognitive Functioning Scale.

Secondary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Eghbali

Torbate-Heidaria University of Medical Sciences

eghbali.msn@gmail.com+98 51 5222 9202

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026