Investigating the Effect of Royal jelly on the Level of Consciousness of Head Trauma Patients Hospitalized in the Intensive Care Unit
Design
Randomized clinical trial with control group, With parallel groups, Double blinded, Phase 3 on 30 patients in each group, Randomization using the random blocking method.
Settings and conduct
The study will be done at the Intensive Care Unit of Musavi Hospital in Zanjan. Patients are blind to the type of intervention and the research assistant who will control the level of consciousness as a result will be blind to the random allocation and type of intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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. Exclusion criteria: 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.
Intervention groups
In the intervention group 3000 mg of Royal jelly solution dissolved in 30 ml of water will be given to the patients twice a day for 14 days. The control group will only receive routine care and the level of consciousness will be measured by Glasgow coma scale (GCS) and FOUR scale daily for 14 days in each group.
Main outcome variables
Level of consciousness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150805023520N4
Registration date:2020-06-29, 1399/04/09
Registration timing:prospective
Last update:2020-06-29, 1399/04/09
Update count:0
Registration date
2020-06-29, 1399/04/09
Registrant information
Name
Nasrin Hanifi
Name of organization / entity
Zanjan University of Medical Scienses
Country
Iran (Islamic Republic of)
Phone
+98 24 3377 2513
Email address
nasrinhanifi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-30, 1399/04/10
Expected recruitment end date
2020-10-31, 1399/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Royal jelly on the Level of Consciousness of Head Trauma Patients Hospitalized in the Intensive Care Unit
Public title
Effect of Royal jelly on the Level of Consciousness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Science
Street address
Zanjan University of Medical Science, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.ZUMS.REC.1399.058
Health conditions studied
1
Description of health condition studied
Traumatic Brain Injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
Level of Consciousness
Timepoint
after intervention, The second to fourteenth day of hospitalization
Method of measurement
GCS and FOUR score
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Zahra Shafeie
Street address
Mousavi Hospital, Road Gavazng
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
shafiee.ccn97@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shogli
Street address
Vice-Chancellery for Research, Zanjan University of Medical Science
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3301 8000
Email
shafiee.ccn97@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Hanifi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Hanifi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Hanifi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Zanjan University of Medical Sciences, shahrak karmandan, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513956113
Phone
+98 24 3314 8318
Email
nasrinhanifi@gmail.com
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