IRCT20131204015649N5 IRCT 2023-05-18 Tehran University of Medical Sciences 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 2024-02-01 anticipated 63 Complete https://irct.ir/trial/69601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, 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 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. N/A Patients with traumatic brain injury. 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, Department of Traditional Pharmacy. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is Currently, no decision has been made in this regard by the team