Effect of MS14, an herbal marine drug on physical activity improvement in patients with multiple sclerosis; a double blind, placebo controlled study

Assessment of natural product, MS14 effect on movement disorder improvement of patients with multiple sclerosis

In this study, 100 patients with multiple sclerosis who fulfill the inclusion criteria of the study are entered the trial. They are divided in two groups randomly; MS14 and placebo. To blind the participants, they receive special codes.

The study is performed in Iranian Center of Neurological Research in Tehran University of Medical Sciences. MS14 and placebo get a specific code. They are similar in face. Patients and physicians who assess the clinical symptoms, are not aware about the content of each sample.

Inclusion criteria: Patients whose symptoms fulfill MS diagnosis criteria; Minimum age of 18 years old; Problems in walking, Ability to walk more than 5 meters with or without help, Stability of disease condition during past 6 months. Exclusion criteria: Using other drugs effective in movement; Using other natural remedies; Cardiovascular diseases; Pregnancy, Disease relapse during the trial, Having active and known infection, Like to use another new drug effective on patient's symptoms, Major cognitive disorder or psychotic disease, Advanced movement disorder like fixed tendon contracture, Abnormality in blood test in beginning of the study, Major depression.

In this study, participants will be divided into placebo and MS14 (drug) groups. Each group will receive MS14 or placebo 50 milligrams for 1 kilogram of body weight. Clinical symptoms will be assessed before and 3 weeks after the intervention.

Job related activities, walking distance during the day, transportation; physical activity, moderate physical activity and general physical activity according to international physical activity questionnaire will be assessed.

In this study, we divide patients into drug and control groups by randomization. according to the number of patients in each group, Drug and placebo are coded using random numbers by biostatistics group and then are given to related physicians.

All of the participants and also physicians who give the placebo or drug to the patients and assess the clinical symptoms before and after the intervention, are unaware about the content of samples. MS14 and placebo samples have similar appearances. There are codes on the package of samples and only the statistics analyst is aware of content of each code. The physician give the sample to the patients, while he does not know the content of each code.