Caspian Journal of Internal Medicine

en 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 Traditional Medicine Original Article Original Article Background: The purpose of this study was to investigate the efficacy and safety of Jollab monzej (JMZ), a Traditional Persian compound medicine, on multiple sclerosis-related fatigue (MSRF). Methods: We did a double-blind randomized controlled phase3 clinical trial on the JMZ syrup in fifty-six relapsing-remitting MS (RRMS) patients aged 18-55 years with moderate to severe fatigue using the Expanded Disability Status Scale (EDSS) score ≤ 6. We randomly assigned (1;1) participants to the JMZ syrup or placebo syrup groups treated for one month. Participants, investigators, and assessors were unaware of the assignments. The primary outcome was changes in the fatigue score on the Fatigue Severity Scale (FSS), at baseline and one month after treatment using the intention-to-treat (ITT) analysis. The secondary outcomes were changes in the score of Visual Analogue Scale (VAS), Beck Depression Inventory (BDI), and Pittsburgh Sleep Quality Index (PSQI). Outcomes were measured at baseline, one month after treatment, and 2-week follow-up. Safety was detected in all participants. Results: We randomly assigned 56 participants to the JMZ group (n=28) and placebo group (n=28). Fatigue scores significantly changed in both groups; however, the JMZ group had a greater reduction in FSS score in the ITT analysis. The adjusted mean difference was 8.80 (Confidence interval (CI) 95%, 2.90-14.70, P = 0.00). The mean difference of VAS, BDI, and global PSQI scores were statistically significant (P=0.01, P₌0.00, P₌0.01; respectively). Regarding safety, mild adverse events (AEs) were reported. Conclusion: The results of our study revealed that the administration of JMZ syrup alleviated MSRF and also could improve depression and sleep disorders. multiple sclerosis, fatigue, herb, Persian Medicine 257 266 http://caspjim.com/browse.php?a_code=A-10-2523-1&slc_lang=en&sid=1 Fatemeh Yousefnia Babaki fyousefnia@sbmu.ac.ir 100319475328460041860 100319475328460041860 No Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Mahmood Khodadoost mkhodadoost@sbmu.ac.ir 100319475328460041861 100319475328460041861 No Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran Hossein Rezaeizadeh hosseinrezaeizade@gmail.com 100319475328460041862 100319475328460041862 No School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran Abdorreza Naser Moghadasi abdorrezamoghadasi@gmail.com 100319475328460041863 100319475328460041863 No Multiple sclerosis Research Center, Neuroscience institute, Tehran University of Medical Sciences, Tehran, Iran Shirin Fahimi fahimishirin@yahoo.com 100319475328460041864 100319475328460041864 No Traditional Medicine and Materia Medica Research center and Department of Traditional Pharmacy, School of Traditional Medicine , Shahid Beheshti University of Medical Sciences, Tehran, Iran Hamed Hosseini hmdhosseini@gmail.com 100319475328460041865 100319475328460041865 No Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran University of Medical Sciences (TUMS), Tehran, Iran Mina Movahhed movahhedm54@gmail.com 100319475328460041866 100319475328460041866 No Traditional Medicine and Materia Medica Research center, Shahid Beheshti University of Medical Sciences, Tehran, Iran Kurosh Gharagozli Gharagozli@yahoo.com 100319475328460041867 100319475328460041867 Yes 6. Brain mapping research Center, Loghman Hakim educational hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran