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IRCT20190518043619N1 IRCT 2020-01-26 Islamic Azad University Studying the Effect of Cinnamon Oral Drop on Balance and Fear of Falling in Patients with Multiple Sclerosis (MS) Studying the Effect of Cinnamon Oral Drop on Balance and Fear of Falling in Patients with Multiple Sclerosis Member of MS Association in Isfahan in 2018 2018-12-13 anticipated 60 Complete https://irct.ir/trial/39673 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, available or easy sampling was used since all the samples were not available. Then, the samples with the inclusion criteria, after getting written consent by using a Random Picker Software from Play Store, which was already installed on the cellphone, and telling the help-seeker to hit the specified phone screen, were placed in Group A or B. 30 individuals were placed in the intervention group, and 30 were placed in the control group. During the intervention, 8 individuals in the intervention group and 5 in the control group were excluded due to the unwillingness to cooperate or relapse of the disease, that the researcher performed further sampling to replace them, Blinding description: It was necessary to prepare a 15 ml glass container for making placebo. Since the Cinnamon Drop lid had the logo of the manufacturer, twice of the lids were purchased to replace them. Glassware, cinnamon drops and mineral water were prepared for making placebo and homogenization, and were sent to the laboratory to perform homogenizing and coding without the presence of the researcher. In the laboratory, all the dishes and cabs (heads) were washed using dishwashing liquid and water and then were placed in an autoclave at 120℃ to ensure the process was sterile. By consulting to the pharmacist consultant and the Research Deputy of Medical Sciences of the University, 14.5 cc of mineral water and 5.5 cc of cinnamon drop were used by a dropper, and then labeled and coded. Labels of the dishes with cinnamon drop were washed and cleaned, and their lids were replaced, labeled and then coded; the placebo-making process was performed by a third party, and the researcher did not know whether the drugs were placebo or origin. Before getting the informed consent, the samples were informed that the probability of being placed in each of the intervention and control group was 50%, and if they were placed in the placebo group, it would be safe for them because placebo is a harmless material. At the end of the research, data analyzer and data evaluator were not aware of which groups A or B was the intervention group, and only the mark of A and B was used in the questionnaire to identify the groups. 3 Multiple Sclerosis. Intervention 1: Intervention group: Patients in the intervention group consumed 4 drops of cinnamon extract three times in a day (morning, noon, and night) with a glass of tea, water or milk, and examinations were performed using Berg balance scale and by fear of falling questionnaire on the first day, and at the end of the first, second, and third months. Intervention 2: Control group: Patients in control group consumed four drops of placebo in three servings (morning, noon, and night) with a glass of tea, water or milk, and examinations were done using Berg balance scale and the questionnaire of fear of falling on the first day, and at the end of first, second, and third months. Yes - There is a plan to make this available What will be shared: All the results and final data can be shared except for patient data and personal data with the principle of confidentiality in receiving information When: 2019 To whom: Researchers working in academia, people who are engaged in the industry, students, patients and all the individuals interested in obtainting data and documentation are permitted to request data and documentation. Conditions: People are permitted to ask for any data and documentation except patients’ personal information, by observing the principle of confidentiality. Where to obtain: Dr.Sayedali Naji; Islamic Azad University Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran; a_naji@khuisf.ac.ir; 0098 9131150865 Soheila Moghimisarani; Islamic Azad University Isfahan (Khorasgan) Branch, University Blvd, Arqavanieh, Jey Street, Isfahan, Iran; s.moghimisarani@khuisf.ac.ir; 0098 9900076746 How to obtain: People can receive data and documentation by calling, sending emails, or meeting in person. Comments:
public Sayedali Naji
Islamic Azad University, Khurasgan Branch, Isfahan, University Blvd, East J Avenue., Arghavanieh, Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 39998-81551 +98 31 1663 9910 a_naji@khuisf.ac.ir Islamic Azad University scientific Soheila Moghimi sarani
No. 216, 16 Ave., Shahid Fallahi St., Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7185736856 +98 71 3823 4637 s.moghimisarani@khuisf.ac.ir Islamic Azad University Iran (Islamic Republic of) Patient should be with Multiple Sclerosis based on the diagnosis of the neurologist. The patients’ age range should be between 18 and 50 years old. The patients should be with relapsing-remitting MS. The recorded disability measuring scale in the patient's medical record should be ranged from 5.1 to 6. The patient should have permanent and regular treatment for 4 weeks before the intervention. The patient should agree not to use any alternative medications for 7 days prior to the intervention until the end of the intervention. The patients should not participate in regular exercises two months before the intervention. The help-seeker should be interested in participating in this research. 18 years 50 years Both Being pregnant or intending to be pregnant or lacate during the intervention. Having liver and kidney dysfunction. Having cardiovascular or infectional diseases. Having allergy to cinnamon. Having neurological diseases in addition to Multiple Sclerosis. Having an experience of consuming alcohol or drug dependence. G35 Multiple Sclerosis Treatment - Drugs Placebo Intervention group: Patients in the intervention group consumed 4 drops of cinnamon extract three times in a day (morning, noon, and night) with a glass of tea, water or milk, and examinations were performed using Berg balance scale and by fear of falling questionnaire on the first day, and at the end of the first, second, and third months. Control group: Patients in control group consumed four drops of placebo in three servings (morning, noon, and night) with a glass of tea, water or milk, and examinations were done using Berg balance scale and the questionnaire of fear of falling on the first day, and at the end of first, second, and third months. Balance. Timepoint: At the beginning of the research, 1,2, and 3 months after using cinnamon orally. Method of measurement: Berg Balance Scale. Fear of Falling. Timepoint: at the beginning of the study, 1,2, and 3 months after the study. Method of measurement: effectiveness scale questionnaire in falling- international form. Islamic Azad University Approved 2018-12-12 Islamic Azad University, Khurasgan Branch, Isfahan Islamic Azad University, Khurasgan Branch, Isfahan, University Blvd, East J Avenue., Arghavanieh, Isfahan Isfahan Isfehan Iran (Islamic Republic of)