PMID- 37223302
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230525
IS  - 2008-6164 (Print)
IS  - 2008-6172 (Electronic)
IS  - 2008-6164 (Linking)
VI  - 14
IP  - 2
DP  - 2023 Spring
TI  - 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.
PG  - 257-266
LID - 10.22088/cjim.14.2.257 [doi]
AB  - 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.
FAU - Yousefnia Babaki, Fatemeh
AU  - Yousefnia Babaki F
AD  - Department of Traditional Medicine, School of Traditional Medicine, Shahid 
      Beheshti University of Medical Sciences, Tehran, Iran.
FAU - Khodadoost, Mahmood
AU  - Khodadoost M
AD  - Department of Traditional Medicine, School of Traditional Medicine, Shahid 
      Beheshti University of Medical Sciences, Tehran, Iran.
FAU - Rezaeizadeh, Hossein
AU  - Rezaeizadeh H
AD  - School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.
FAU - Naser Moghadasi, Abdorreza
AU  - Naser Moghadasi A
AD  - Multiple sclerosis Research Center, Neuroscience institute, Tehran University of 
      Medical Sciences, Tehran, Iran.
FAU - Fahimi, Shirin
AU  - Fahimi S
AD  - Department of Traditional Pharmacy, Faculty of Pharmacy and Pharmaceutical 
      Sciences, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
FAU - Hosseini, Hamed
AU  - Hosseini H
AD  - Center for Research and Training in Skin Diseases and Leprosy (CRTSDL), Tehran 
      University of Medical Sciences (TUMS), Tehran, Iran.
FAU - Movahhed, Mina
AU  - Movahhed M
AD  - Department of Traditional Pharmacy, Faculty of Pharmacy and Pharmaceutical 
      Sciences, Tehran Medical Sciences, Islamic Azad University, Tehran, Iran.
FAU - Gharagozli, Kurosh
AU  - Gharagozli K
AD  - Brain mapping research Center, Loghman Hakim educational hospital, Shahid 
      Beheshti University of Medical Sciences, Tehran, Iran.
LA  - eng
PT  - Journal Article
PL  - Iran
TA  - Caspian J Intern Med
JT  - Caspian journal of internal medicine
JID - 101523876
PMC - PMC10201133
OTO - NOTNLM
OT  - Fatigue
OT  - Herb
OT  - Multiple sclerosis
OT  - Persian Medicine
OT  - Traditional
COIS- The authors have no conflicts of interests to declare.
EDAT- 2023/05/24 13:08
MHDA- 2023/05/24 13:09
PMCR- 2023/03/01
CRDT- 2023/05/24 11:45
PHST- 2021/11/03 00:00 [received]
PHST- 2022/02/25 00:00 [revised]
PHST- 2022/04/05 00:00 [accepted]
PHST- 2023/05/24 13:09 [medline]
PHST- 2023/05/24 13:08 [pubmed]
PHST- 2023/05/24 11:45 [entrez]
PHST- 2023/03/01 00:00 [pmc-release]
AID - 10.22088/cjim.14.2.257 [doi]
PST - ppublish
SO  - Caspian J Intern Med. 2023 Spring;14(2):257-266. doi: 10.22088/cjim.14.2.257.