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

Determining the Effect of Cinnamon Oral Drop on Balance and Fear of Falling in Patients with MS.

Controlled Clinical Trial with Parallel and Triple Blind Patterns.

Patients with multiple sclerosis, members of the MS Society of Isfahan were studied during three months of study using 4 drops of cinnamon extract in three servings, and before the intervention and each month, they were assessed using Berg balance test and the Falls Efficacy Scale-International. In this research, the patients, the researcher, the person in charge of caring the patients and the statistical data analyst were blinded. The drugs and placebo were replicated in a laboratory environment under sterile conditions by a third party. There was no indication of the originality of drugs, and they were indicated by two groups of A and B.

The participants had multiple sclerosis (MS) according to the neurologist's diagnosis. The patients’ age range was from 18 to 50 years. The patients had relapsing-remitting MS. The recorded disability measurement scale in the patients’ file was from 5.1 to 6. Regular treatment was performed 4 weeks before the intervention. Patients agreed not to use alternative mmedications for 7 days before starting the intervention until the end of the intervention.

The intervention group received 4 drops of cinnamon in three servings (morning, noon, and night) with a glass of tea, water, or milk, and the examinations were done using Berg Balance Scale and the fear of falling questionnaire. In the control group, the protocol was like the placebo group, and they received 4 drops of placebo per serving.

Consumption of Cinnamon oral drop; Balance; Fear of Falling

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.

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.

All the results and final data can be shared except for patient data and personal data with the principle of confidentiality in receiving information

2019

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People are permitted to ask for any data and documentation except patients’ personal information, by observing the principle of confidentiality.

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

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