Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis
NCT ID: NCT05480878
Last Updated: 2023-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2022-12-02
2023-04-01
Brief Summary
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Detailed Description
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A total of 90 RA patients recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).
RA Patients who will meet the inclusion criteria will be enrolled in the study.
They will be classified into three groups:
Group 1: 30 RA patients who will receive the traditional therapy of rheumatoid arthritis for 12 weeks and serve as the control group.
Group 2: 30 RA patients who will receive traditional therapy plus Nitazoxanide 1 gm/day for 12 weeks.
Group 3: 30 RA patients who will receive traditional therapy plus Escitalopram 10 mg/day for 12 weeks.
Clinical Examinations and laboratory parameters will be performed and measured at the beginning of the study and 3 months after randomization to evaluate the efficacy of Nitazoxanide and Escitalopram in the treatment of rheumatoid arthritis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 12 weeks.
.
Placebo
Placebo will be administered to the control group for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Nitazoxanide
Participants in this arm will receive Nitazoxanide 1 gm/day + DMARDs for 12 weeks.
Nitazoxanide 500Mg Oral Tablet
All subjects will receive Nitazoxanide 500gm twice daily for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Escitalopram
Participants in this arm will receive Escitalopram 10 mg/day + DMARDs for 12 weeks.
Escitalopram 10mg
All subjects will receive Escitalopram 10 mg/day for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Interventions
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Placebo
Placebo will be administered to the control group for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Nitazoxanide 500Mg Oral Tablet
All subjects will receive Nitazoxanide 500gm twice daily for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Escitalopram 10mg
All subjects will receive Escitalopram 10 mg/day for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Eligibility Criteria
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Inclusion Criteria
* Receiving conventional disease modified anti rheumatic drugs (DMARDS).
* Having active disease (the 28-joint disease activity score \[DAS28\] according to the CRP formula \> 2.6).
* Age between 18 and 75 years.
* Conscious and cooperative.
* Male or female.
* Sign an informed consent for the clinical study
Exclusion Criteria
2. Chronic disease.
3. Other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.
4. Patients treated with biological TNF-α, IL6 or IL-1β antagonists.
5. Infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases.
6. Clinically significant hepatic and renal dysfunction or impairment.
7. Alcohol abuse
8. Receiving therapy that interact with Nitazoxanide and Escitalopram.
9. Hypersensitivity to Nitazoxanide and Escitalopram.
18 Years
75 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Abeer Abdelmhsen Elsayed Elmotwally
Assistant lecturer at clinical pharmacy department ,faculty of pharmacy, Tanta university
Locations
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Tanta university
Tanta, , Egypt
Countries
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References
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Smolen JS, Aletaha D, Barton A, Burmester GR, Emery P, Firestein GS, Kavanaugh A, McInnes IB, Solomon DH, Strand V, Yamamoto K. Rheumatoid arthritis. Nat Rev Dis Primers. 2018 Feb 8;4:18001. doi: 10.1038/nrdp.2018.1.
Li Y, de Haar C, Peppelenbosch MP, van der Woude CJ. New insights into the role of STAT3 in IBD. Inflamm Bowel Dis. 2012 Jun;18(6):1177-83. doi: 10.1002/ibd.21884. Epub 2011 Oct 12.
Wu X, Shou Q, Chen C, Cai H, Zhang J, Tang S, Cai B, Tang D, Cao G. An herbal formula attenuates collagen-induced arthritis via inhibition of JAK2-STAT3 signaling and regulation of Th17 cells in mice. Oncotarget. 2017 Jul 4;8(27):44242-44254. doi: 10.18632/oncotarget.17797.
Aboudounya MM, Heads RJ. COVID-19 and Toll-Like Receptor 4 (TLR4): SARS-CoV-2 May Bind and Activate TLR4 to Increase ACE2 Expression, Facilitating Entry and Causing Hyperinflammation. Mediators Inflamm. 2021 Jan 14;2021:8874339. doi: 10.1155/2021/8874339. eCollection 2021.
Li CH, Lu ZR, Zhao ZD, Wang XY, Leng HJ, Niu Y, Wang MP. Nitazoxanide, an Antiprotozoal Drug, Reduces Bone Loss in Ovariectomized Mice by Inhibition of RANKL-Induced Osteoclastogenesis. Front Pharmacol. 2021 Dec 9;12:781640. doi: 10.3389/fphar.2021.781640. eCollection 2021.
Lu Z, Li X, Li K, Wang C, Du T, Huang W, Ji M, Li C, Xu F, Xu P, Niu Y. Structure-Activity Study of Nitazoxanide Derivatives as Novel STAT3 Pathway Inhibitors. ACS Med Chem Lett. 2021 Apr 1;12(5):696-703. doi: 10.1021/acsmedchemlett.0c00544. eCollection 2021 May 13.
Gong F, Shen T, Zhang J, Wang X, Fan G, Che X, Xu Z, Jia K, Huang Y, Li X, Lu H. Nitazoxanide induced myocardial injury in zebrafish embryos by activating oxidative stress response. J Cell Mol Med. 2021 Oct;25(20):9740-9752. doi: 10.1111/jcmm.16922. Epub 2021 Sep 17.
Sacre S, Medghalchi M, Gregory B, Brennan F, Williams R. Fluoxetine and citalopram exhibit potent antiinflammatory activity in human and murine models of rheumatoid arthritis and inhibit toll-like receptors. Arthritis Rheum. 2010 Mar;62(3):683-93. doi: 10.1002/art.27304.
Gupta S, Upadhayay D, Sharma U, Jagannathan NR, Gupta YK. Citalopram attenuated neurobehavioral, biochemical, and metabolic alterations in transient middle cerebral artery occlusion model of stroke in male Wistar rats. J Neurosci Res. 2018 Jul;96(7):1277-1293. doi: 10.1002/jnr.24226. Epub 2018 Apr 15.
Aletaha D, Neogi T, Silman AJ, Funovits J, Felson DT, Bingham CO 3rd, Birnbaum NS, Burmester GR, Bykerk VP, Cohen MD, Combe B, Costenbader KH, Dougados M, Emery P, Ferraccioli G, Hazes JM, Hobbs K, Huizinga TW, Kavanaugh A, Kay J, Kvien TK, Laing T, Mease P, Menard HA, Moreland LW, Naden RL, Pincus T, Smolen JS, Stanislawska-Biernat E, Symmons D, Tak PP, Upchurch KS, Vencovsky J, Wolfe F, Hawker G. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-81. doi: 10.1002/art.27584.
Nishimoto N, Takagi N. Assessment of the validity of the 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) as a disease activity index of rheumatoid arthritis in the efficacy evaluation of 24-week treatment with tocilizumab: subanalysis of the SATORI study. Mod Rheumatol. 2010 Dec;20(6):539-47. doi: 10.1007/s10165-010-0328-0. Epub 2010 Jul 10.
Other Identifiers
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Rheumatoid Arthritis
Identifier Type: -
Identifier Source: org_study_id
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