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IRCT20180818040827N4 IRCT 2021-10-16 Esfahan University of Medical Sciences Effect of royal jelly in treatment of stroke 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 2021-11-22 anticipated 64 Complete https://irct.ir/trial/59275 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Ischemic stroke. Intervention 1: 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). Intervention 2: 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). Yes - There is a plan to make this available What will be shared: A major part of the information will be available for the population When: 12 months after publication To whom: Available for people working in academic institutions Conditions: To conduct similar studies Where to obtain: Reza Amani How to obtain: The data will be sent as soon as possible after receiving the request Comments:
public Reza Amnai
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jarib Blvd
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 3668 1378 rezaamani@hotmail.com Esfahan University of Medical Sciences scientific Reza Amnai
School of Nutrition and Food Science, Isfahan University of Medical Sciences, Hezar Jarib Blvd
Isfehan Iran (Islamic Republic of) 8174673461 +98 31 3668 1378 rezaamani@hotmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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 45 years 80 years Both 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 G46.4 Cerebellar stroke syndrome Rehabilitation Placebo 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). 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). Superoxide dismutase. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Glutathione peroxidase. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Malonaldehyde. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Total antioxidant capacity. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Total oxidant status. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Nitric oxide. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetric method. Brain derived neurotrophic factor. Timepoint: At baseline and after 12 weeks. Method of measurement: ELISA method. Modified Rankin Scale. Timepoint: At baseline and after 12 weeks. Method of measurement: Questionnaire. Stroke specific quality of life. Timepoint: At baseline and after 12 weeks. Method of measurement: Questionnaire. Cognitive function. Timepoint: At baseline and after 12 weeks. Method of measurement: MMSE questionnaire. Fatigue score. Timepoint: At baseline and after 12 weeks. Method of measurement: FSS questionnaire. Uric acid. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetry. C-reactive protein. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetry. Erythrocyte sedimentation rate. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetry. Blood pressure. Timepoint: At baseline and after 12 weeks. Method of measurement: sphygmomanometer. Lipid profile. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetry. Fasting Blood Glucose. Timepoint: At baseline and after 12 weeks. Method of measurement: Colorimetry. Stress score. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21 questionnaire. Depression score. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21 questionnaire. Anxiety score. Timepoint: At baseline and after 12 weeks. Method of measurement: DASS-21 questionnaire. Appetite score. Timepoint: At baseline and after 12 weeks. Method of measurement: SNAQ questionnaire. Mid arm circumference. Timepoint: At baseline and after 12 weeks. Method of measurement: Tape meter. Esfahan University of Medical Sciences Approved 2021-10-09 Ethics committee of Isfahan University of Medical Sciences Hezarjrib Street Isfahan Isfehan Iran (Islamic Republic of)