Investigating the effect of Femi Locket on the fatigue of multiple sclerosis patients referring to the clinics of Arak University of Medical Sciences

Investigating the effect of Familact on the fatigue of multiple sclerosis patients

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 30 patients.

This study is a double-blind study on multiple sclerosis patients who have been suffering from this disease for at least 6 months. In this way, after obtaining permission from the university's research council, patients referred to the clinics of Arak University of Medical Sciences are examined based on clinical examinations by neurologists and paraclinical results to confirm the diagnosis of multiple sclerosis. The patients were randomly divided into two experimental and control groups, the experimental group was also prescribed Familact 500 mg per day in addition to the standard drugs. Homogeneous in the control group, in addition to standard drugs, a placebo drug is also given. At zero time and after 30 and 60 days of drug administration, the patients were assessed for fatigue caused by multiple sclerosis using the standard "Fatigue Severity Scale" (FSS) checklist.

Having a history of multiple sclerosis for 6 months Neurological examination and brain CT scan and ruling out brain tumors and space-occupying lesions Absence of mental illnesses including depression and absence of psychiatric problems and nervous headaches Absence of accompanying diseases that cause fatigue, including thyroid diseases and anemia - Exit criteria: Reluctance to continue studying Presence of sensitivity to Familact

Familact group

Fatigue

The names of all patients will be written completely randomly from top to bottom after sampling the required amount (30 people) using the available (easy) sampling method; Then, from the top, we assign number 1 to the first person, then 2 to... the last person to whom we assign the number 30. Then numbers 1 to 15 will be assigned to the control group and numbers 16 to 30 to the intervention group.

In this study, only the patients and the project manager who is supposed to perform the intervention on the patients; They will be blind. In this way, the empty capsule will be prepared exactly the same as the Familact capsule, and 30 glasses will be prepared for the drugs. According to the randomization, glasses 1 to 15 will contain 3 empty capsules each and glasses number 16 to 30 will contain 3 Familact capsules each. In this way, both the project manager and the patient will not know whether the capsule they receive is Familact or a placebo.

All information and data will be shared after de-identifying people.

Access will start 1 month after the results are published.

All people related to medical and health matters

The use of data will only be subject to mention of the source of the study and the authors. It is definitely necessary to obtain permission from the authors and researchers of the study.

With this E-Mail:Mahdisafarabadi@gmail.com

After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester.