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IRCT20190623043984N1 IRCT 2020-01-10 Shahid Beheshti University of Medical Sciences Effect of "Jollab-e-monzej" for the treatment of MS-related fatigue 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 2020-01-21 anticipated 56 Complete https://irct.ir/trial/41920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Multiple sclerosis. Intervention 1: Intervention group: Intervention group 1: Jollab-e-monzej syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month. Intervention 2: Control group:Intervention group 2: Placebo syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is not enough reason to do so for now
public Fatemeh Yousefnia Babaki
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 fyousefnia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fatemeh Yousefnia Babaki
Faculty of Traditional Medicine, Shahid Beheshti University of Medical Sciences, No. 8, Shams Alley, Valiasr Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1516745811 +98 21 8877 3521 fyousefnia@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) -Multiple sclerosis patients, female or male -Age range 18-55 years -Patients with relapsing-remitting MS -MS patients with EDSS of less than or equal to 6 -MS patients are suffering from fatigue and insomnia -Fatigue score greater than or equal to 36 on the FSS questionnaire -Consent to participate in the study 18 years 55 years Both -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 and/or consumption of corticosteroides over the past three months G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Intervention group 1: Jollab-e-monzej syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month. Control group:Intervention group 2: Placebo syrup, which the participants consume in the morning and evening, 20 to 30 ml, depending on their weight, for one month. Fatigue score on the fatigue severity scale questionnaire. Timepoint: Measurement of fatigue score at baseline and after one month (intervention period) and also two weeks after intervention period. Method of measurement: Fatigue severity scale questionnaire. Fatigue score on the visual analogue score. Timepoint: Measurement of fatigue score at baseline and after one month (intervention period) and also two weeks after intervention period. Method of measurement: The Visual analogue scale (VAS). Global sleep quality score on the PSQI questionnaire. Timepoint: Measurement of global sleep quality score at baseline and after one month (intervention period) and also two weeks after intervention period. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI). Depression score on BDI questionnaire. Timepoint: Measurement of depression score at baseline and after one month (intervention period) and also two weeks after intervention period. Method of measurement: Beck depression inventory questionnaire (BDI). Shahid Beheshti University of Medical Sciences Approved 2019-03-17 Ethical committee of Shahid Beheshti University of medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak,Shahid Beheshti University of medical Sciences, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)