Efficacy and safety of “Jollab monzej” as a traditional Persian compound medicine for the treatment of multiple sclerosis-related fatigue: A randomized placebo-controlled trial

Determination of efficacy and safety of “Jollab monzej” as a traditional Persian compound medicine for the treatment of multiple sclerosis-related fatigue compared with placebo

56 participants in phase 3, double-blind parallel group, randomized clinical trial with outcome assessment, based on random sheets of code in sealedenvelope site, were assigned to either the drug or placebo intervention groups.

The study runs after approval of the proposal, registration with research center and permission from the Ethics Committee, and registration with the Center Iran's clinical trial.Patients with multiple sclerosis, referred to the neurologist's office and Iran MS society, were randomly divided into two intervention groups, based on inclusion and exclusion criteria.FSS, PSQI, BDI and VAS questionnaires are completed for each individual at the bigining and end of one month (completion of treatment) and also two week after that, again.

Inclusion criteria -Multiple sclerosis (MS) patients, female or male -Age range 18-55 years -Patients with relapsing-remitting MS -MS patients with EDSS ≤ 6 -MS patients are suffering from fatigue -Fatigue score ≥ 36 on the FSS questionnaire -Consent to participate in the study No inclusion criteria -Pregnancy and lactation -The comorbidity of severe and chronic disease -known active infection -Suffering from psychosis or dementia -Depression in BDI questionnaire -Patients with a change in main drug of MS, over the past three months -Patients with relapse or consumption of corticosteroids, over the past three months

In this study, drug group receive, the traditional persian compound medicine, and placebo group, consume a product; containing a small amount of one component of the drug.

Jollab-e-monzej; Fatigue

In the study implementation phase due to the intersection of participants recruitments of the study with the prevalence of COVID-19, and considering the completion of the sample size of the study fatigue section, the research team decided to end the study to prevent possible complications of the intervention due to uncertain conditions and effects of coronavirus in MS patients. , and evaluate the efficacy and safety of the traditional medicine product on MS fatigue as a primary outcome and insomnia as a secondary outcome. Based on this, changes were made in the title and sample size of the study, which are reported.

After calculating the final sample size of the study, Random chains are generated based on simple random series using permuted block at sealedenvelope site for two intervention and comparison groups. Then a matched code will be generated for each sequence, based on random chain, which contains two letters of the alphabet and one number.The anonymous code is pasted on the study drugs (research label) before starting the study and also are stored.During the study, patients are given medication, according to the sequence of patient's entry and randomization sheets (containing only anonymous codes) of the medications stored.Therefore, the research drug distributors and participants in the study are blinded to the assigned group.

In this study, the researcher who performs process, is also clinical caregiver and outcome evaluator that assigns participants based on randomization codes sheets into two groups; intervention medication group and intervention placebo group.During the study, patients are given medication, according to the sequence of patient's entry and randomization sheets (containing only anonymous codes) of the medications stored.Therefore, the research drug distributors and participants in the study are blinded to the assigned group. The pharmacist as well as the data analyzer get inform about group assignment.