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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
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 rel...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Babol University of Medical Sciences
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10201133/ https://www.ncbi.nlm.nih.gov/pubmed/37223302 http://dx.doi.org/10.22088/cjim.14.2.257 |
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author | Yousefnia Babaki, Fatemeh Khodadoost, Mahmood Rezaeizadeh, Hossein Naser Moghadasi, Abdorreza Fahimi, Shirin Hosseini, Hamed Movahhed, Mina Gharagozli, Kurosh |
author_facet | Yousefnia Babaki, Fatemeh Khodadoost, Mahmood Rezaeizadeh, Hossein Naser Moghadasi, Abdorreza Fahimi, Shirin Hosseini, Hamed Movahhed, Mina Gharagozli, Kurosh |
author_sort | Yousefnia Babaki, Fatemeh |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10201133 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Babol University of Medical Sciences |
record_format | MEDLINE/PubMed |
spelling | pubmed-102011332023-05-23 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 Yousefnia Babaki, Fatemeh Khodadoost, Mahmood Rezaeizadeh, Hossein Naser Moghadasi, Abdorreza Fahimi, Shirin Hosseini, Hamed Movahhed, Mina Gharagozli, Kurosh Caspian J Intern Med 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. Babol University of Medical Sciences 2023 /pmc/articles/PMC10201133/ /pubmed/37223302 http://dx.doi.org/10.22088/cjim.14.2.257 Text en https://creativecommons.org/licenses/by/3.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License, (http://creativecommons.org/licenses/by/3.0/ (https://creativecommons.org/licenses/by/3.0/) ) which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Yousefnia Babaki, Fatemeh Khodadoost, Mahmood Rezaeizadeh, Hossein Naser Moghadasi, Abdorreza Fahimi, Shirin Hosseini, Hamed Movahhed, Mina Gharagozli, Kurosh 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10201133/ https://www.ncbi.nlm.nih.gov/pubmed/37223302 http://dx.doi.org/10.22088/cjim.14.2.257 |
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