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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 Publisher



Babaki FY1 ; Khodadoost M1 ; Rezaeizadeh H2 ; Moghadasi AN3 ; Fahimi S4 ; Hosseini H5 ; Movahhed M4 ; Gharagozli K6
Authors
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Authors Affiliations
  1. 1. Department of Traditional Medicine, School of Traditional Medicine, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. Multiple sclerosis Research Center, Neuroscience institute, Tehran University of Medical Sciences, Tehran, Iran
  4. 4. Department of Traditional Pharmacy, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran
  5. 5. Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran University of Medical Sciences (TUMS), Tehran, Iran
  6. 6. Brain mapping research Center, Loghman Hakim educational hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Source: Caspian Journal of Internal Medicine Published:2023


Abstract

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. © 2022 The Author(s)
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