Protocol summary
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Study aim
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Evaluation of the effect of Royal Jelly supplementation on inflammatory status, oxidative stress, mental health, cognitive function, disease severity, and quality of life in patients with ischemic stroke
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Design
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A parallel randomized triple-blind placebo-controlled clinical trial
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Settings and conduct
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Participants will be selected from patients with ischemic stroke referred to Al-Zahra Hospital. By reviewing the patient file, individuals will be evaluated based on the inclusion criteria and individuals who meet the conditions to participate in the study will be included in the study. The intervention group will receive one tablet of Royal Jelly (containing 1000 mg of Royal Jelly powder) daily after breakfast and the control group will receive one placebo daily, which is similar in shape, color, taste, and smell. Patients, researchers, and those performing statistical analysis are not aware of how randomly assigned individuals are.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diagnosis of ischemic stroke, age 45-80 years, no other diseases such as acute kidney, liver, heart, other neurological diseases, malignancies, asthma, allergies and dermatitis
Exclusion criteria: Unwillingness of people to continue the study for any reason, adherence less than 80%, recurrence of stroke
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Intervention groups
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Intervention group: The intervention group will receive one tablet of Royal Jelly (containing 1000 mg of Royal Jelly powder) daily after breakfast.
Control group: The control group will receive one placebo daily which is similar to Royal Jelly supplement in terms of shape, color, taste and smell.
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Main outcome variables
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The aim of this study was to evaluate the effect of Royal Jelly supplementation on inflammatory status, oxidative stress, mental health, cognitive function, disease severity, and quality of life in patients with ischemic stroke.
General information
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Reason for update
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Alteration of sample size calculation formula
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180818040827N4
Registration date:
2021-10-16, 1400/07/24
Registration timing:
prospective
Last update:
2022-08-02, 1401/05/11
Update count:
1
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Registration date
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2021-10-16, 1400/07/24
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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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2021-11-22, 1400/09/01
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Expected recruitment end date
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2022-08-23, 1401/06/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of royal jelly supplementation on inflammatory status, oxidative stress, mental health, cognitive function, disease severity and quality of life in patients with ischemic stroke
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Public title
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Effect of royal jelly in treatment of stroke
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Confirmed diagnosis of ischemic stroke by a neurologist
NIHSS score of 5-20
An absence of previous stroke or or MRS score of ≤ 1 for those with previous stroke
Ischemic stroke of non-brain stem area
age of 45-80
Not following specific dietary regimen in previous 3 months
Not taking multivitamins and antioxidant supplements in the previous 3 months
Non pregnant and lactating women
No other diseases such as acute kidney, liver, heart, other neurological diseases, malignancies, no asthma, allergies and dermatitis
Not suffering from mental retardation (mental disabilities)
Not taking drugs that interfere with Royal Jelly supplementation (warfarin)
Lack of sensitivity and allergy to honey and its products
Exclusion criteria:
Unwillingness to continue the study for any reason
Adherence of less than 80% to the intervention (taking less than 80% of Royal Jelly supplement that should be taken during the 12 weeks of the intervention will be considered low adherence)
Recurrence of stroke
Death
Use of antioxidant and multivitamin supplements during the study
Prescription of warfarin during the study
Gastrointestinal side effects or allergies caused by taking Royal Jelly supplement
Diagnosis of other diseases such as kidney, autoimmune and malignancies during the study
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Age
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From 45 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was performed by permuted block randomization method using size 6 blocks by Stata statistical software version 16. To conceal the random assignment process, 10-digit random codes are written on 64 paper labels without a specific order and framework, which is the relevant treatment identification number, and only one person outside the design will be aware of the code. Labels will be affixed to drug packages in a random order list.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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Drugs and placebo are given to both groups in completely identical, unlabeled containers, which are prepared and coded in the same color and odor, by random allocation by the design partner, so neither patient is aware of the specific treatment and will not be informed until the end of the study. Also, the researcher evaluating the desired outcomes is unaware of the random allocation process and the type of treatment performed. In order to analyze the data, a statistician and epidemiologist who is separate from the study process and is unaware of all the processes performed will be used.
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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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2021-10-09, 1400/07/17
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Ethics committee reference number
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IR.MUI.RESEARCH.REC.1400.291
Health conditions studied
1
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Description of health condition studied
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Ischemic stroke
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ICD-10 code
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G46.4
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ICD-10 code description
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Cerebellar stroke syndrome
Primary outcomes
1
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Description
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Superoxide dismutase
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
2
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Description
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Glutathione peroxidase
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
3
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Description
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Malonaldehyde
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
4
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Description
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Total antioxidant capacity
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
5
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Description
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Total oxidant status
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
6
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Description
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Nitric oxide
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetric method
7
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Description
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Brain derived neurotrophic factor
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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ELISA method
8
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Description
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Modified Rankin Scale
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Questionnaire
9
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Description
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Stroke specific quality of life
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Questionnaire
10
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Description
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Cognitive function
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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MMSE questionnaire
11
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Description
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Fatigue score
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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FSS questionnaire
12
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Description
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Uric acid
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetry
13
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Description
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C-reactive protein
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetry
14
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Description
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Erythrocyte sedimentation rate
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetry
15
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Description
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Blood pressure
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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sphygmomanometer
16
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Description
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Lipid profile
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetry
17
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Description
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Fasting Blood Glucose
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Colorimetry
Secondary outcomes
1
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Description
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Stress score
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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DASS-21 questionnaire
2
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Description
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Depression score
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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DASS-21 questionnaire
3
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Description
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Anxiety score
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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DASS-21 questionnaire
4
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Description
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Appetite score
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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SNAQ questionnaire
5
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Description
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Mid arm circumference
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Timepoint
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At baseline and after 12 weeks
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Method of measurement
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Tape meter
Intervention groups
1
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Description
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Intervention group: The intervention group will receive one tablet of Royal Jelly (containing 1000 mg of Royal Jelly powder) daily after breakfast for 12 weeks. Royal Jelly supplement will be provided by Koozeh Asal Aria Company (Iran-Isfahan).
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Category
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Rehabilitation
2
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Description
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Control group: The control group will receive a placebo daily supplement that is similar in shape, color, taste, and smell to the supplement. The placebo will be provided by Koozeh Asal Aria Company (Iran-Isfahan).
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Category
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Placebo
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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Esfahan 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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A major part of the information will be available for the population
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When the data will become available and for how long
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12 months after publication
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To whom data/document is available
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Available for people working in academic institutions
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Under which criteria data/document could be used
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To conduct similar studies
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From where data/document is obtainable
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Reza Amani
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What processes are involved for a request to access data/document
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The data will be sent as soon as possible after receiving the request
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Comments
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