Caspian Journal of Internal Medicine
1
Caspian J Intern Med
Medical Sciences
http://caspjim.com
1
admin
2008-6164
2008-6172
8
10.22088/cjim
14
8888
13
en
jalali
1401
12
1
gregorian
2023
3
1
14
2
online
1
fulltext
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
<span style="font-size:14px;"><span style="font-family:Times New Roman;"><span style="line-height:14pt"><b><i><span style="color:blue">Background:</span></i></b> 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).<span style="font-size:9.0pt"></span></span><br>
<span style="line-height:14pt"><b><i><span style="color:blue">Methods:</span></i></b> 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 <sub>syrup</sub> 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.<span style="font-size:10.0pt"></span></span><br>
<span style="line-height:14pt"><b><i><span style="color:blue">Results:</span></i></b> 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.<b><i><span style="color:blue"></span></i></b></span><br>
<span style="line-height:14pt"><b><i><span style="color:blue">Conclusion:</span></i></b><b> </b>The results of our study revealed that the administration of JMZ syrup alleviated MSRF and also could improve depression and sleep disorders.<b><i><span style="color:#0033cc"></span></i></b></span></span></span><br>
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<strong><span dir="RTL"></span></strong>
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