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IRCT20150805023520N4 IRCT 2020-06-29 Zanjan University of Medical Sciences Effect of Royal jelly on the Level of Consciousness Investigating the Effect of Royal jelly on the Level of Consciousness of Head Trauma Patients Hospitalized in the Intensive Care Unit 2020-06-30 anticipated 60 Complete https://irct.ir/trial/48995 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sixty patients will be selected as available and then randomly assigned to two intervention groups (Royal jelly) and the control group using the random blocking method. As such, 6 blocks of 4 are provided as follows.1) AABB 2) ABAB 3) ABBA 4) BBAA 5) BABA 6) BAAB. Block selection is based on the random number table. Group A will receive Royal jelly and group B will be the control group, Blinding description: Given that the patients have a low level of consciousness, they are blind to the type of intervention. Also, the research assistant who will control the level of the patients' awareness as a result will be blind to the random allocation and type of intervention group. 3 Traumatic Brain Injury. Intervention 1: Intervention group: Patients will receive 3000 mg of fresh Royal jelly solution dissolved in 30 ml of water through the mouth or gavage, twice a day for 14 days. The gel used is Royal Jelly, which is a Bee product that is completely natural and has an official license. Royal Jelly belongs to Zanjan Beekeepers Company. The level of consciousness will be measured by Glasgow coma scale (GCS) and Full Outline of Unresponsiveness scale (FOUR) daily for 14 days. Intervention 2: Control group: Patients will only receive routine care and the level of consciousness will be measured by Glasgow coma scale (GCS) and Full Outline of Unresponsiveness scale (FOUR) daily for 14 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more information
public Nasrin Hanifi
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8318 nasrinhanifi@gmail.com Zanjan University of Medical Sciences scientific Nasrin Hanifi
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
Zanjan Iran (Islamic Republic of) 4513956113 +98 24 3314 8318 nasrinhanifi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) To have an age range between 18 and 65 years old To be Admitted with a diagnosis of traumatic brain injury To have 5 to 13 level of consciousness based on Glasgow coma scale Not to be sensitive to Bee product Not to be pregnant To be admitted to the ICU for more than 48 hours Not to be drugs addict Not to have a severe trauma to other organs Not to receive sedative as a continuous infusion To be started Feeding through the mouth or gavage Not to have severe mental illnesses To have hemodynamic stability 18 years 60 years Both discharge or death of the patient before day 14 in each group Lack of willingness to continue participating in the study by the patient's legal guardian at any stage of the study Changes in the patient's condition to prevent the possibility of intervention, such as sending the patient to another hospital, cardiac arrest S06 Intracranial injury Rehabilitation Other Intervention group: Patients will receive 3000 mg of fresh Royal jelly solution dissolved in 30 ml of water through the mouth or gavage, twice a day for 14 days. The gel used is Royal Jelly, which is a Bee product that is completely natural and has an official license. Royal Jelly belongs to Zanjan Beekeepers Company. The level of consciousness will be measured by Glasgow coma scale (GCS) and Full Outline of Unresponsiveness scale (FOUR) daily for 14 days. Control group: Patients will only receive routine care and the level of consciousness will be measured by Glasgow coma scale (GCS) and Full Outline of Unresponsiveness scale (FOUR) daily for 14 days. Level of Consciousness. Timepoint: after intervention, The second to fourteenth day of hospitalization. Method of measurement: GCS and FOUR score. Zanjan University of Medical Sciences Approved 2020-04-28 Ethics Committee of Zanjan University of Medical Science Zanjan University of Medical Science, Azadi Square Zanjan Zanjan Iran (Islamic Republic of)