Hand, foot, and mouth disease: could EPs® 7630 be a treatment option? a prospective randomized open-label multicenter clinical study

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dc.authorscopusidMurat Sütçü / 55499199300
dc.authorscopusidFunda Yıldız / 57226016668
dc.authorscopusidDoruk Gül / 57222108765
dc.authorwosidMurat Sütçü / AAR-5212-2020
dc.authorwosidFunda Yıldız / ITJ-7061-2023
dc.authorwosidDoruk Gül / AGJ-2448-2022
dc.contributor.authorSütçü, Murat
dc.contributor.authorKara, Manolya
dc.contributor.authorYıldız, Funda
dc.contributor.authorKılıç, Ömer
dc.contributor.authorTural Kara, Tuğçe
dc.contributor.authorAkkoç, Gülşen
dc.contributor.authorBüyükçam, Ayşe
dc.contributor.authorElmas Bozdemir, Şefika
dc.contributor.authorÖzgür Gündeşlioğlu, Özlem
dc.contributor.authorGül, Doruk
dc.contributor.authorİseri Nepesov, Merve
dc.contributor.authorKara, Ateş
dc.date.accessioned2025-04-18T10:13:08Z
dc.date.available2025-04-18T10:13:08Z
dc.date.issued2024
dc.departmentİstinye Üniversitesi, Tıp Fakültesi, Dahili Tıp Bilimleri Bölümü
dc.description.abstractPurpose Hand, foot and mouth disease (HFMD) is a viral contagious disease of children caused by human enteroviruses (EVs) and coxsackieviruses (CVs). There is no specific treatment option for HFMD. EPs (R) 7630's anti-infective and immunomodulatory properties have previously been demonstrated in several in vitro and in vivo studies; however, the use of this herbal medicine in children with HFMD has not previously been investigated. Methods This prospective randomized multicenter clinical study included 208 children with HFMD. The diagnosis was made by pediatricians. The patients who were within the first 48 h of symptom onset (according to the first onset of fever and skin findings) were enrolled. The study participants were assigned into 2 groups as EPs (R) 7630 and control groups. All patients were followed up twice more, 48 h after the first admission and on the 5th-7th day. Another phone evaluation was conducted for those with continued complaints from the previous visit. Results The median age was 27 (12-112) months. The male-female ratio was 0.98. One hundred thirty one (63%) of 190 patients had no history of household contact. EPs (R) 7630 group included 94 and control group included 96 patients. A significant difference was found between the groups in terms of complaint scores at the visits made at the 48th h of the treatment and on days 5-7 (p < 0.001). The mean +/- SD disease duration of EPs (R) 7630 users was significantly shorter 6.07 +/- 0.70 days (95% CI: 5.92-6.21)] than the control group [8.58 +/- 0.94 days (95% CI: 8.39-8.77)] (p < 0.001). Besides, the hospitalization rate among the EPs (R) 7630 users were significantly lower (p = 0.019). No side effects were observed, except for unpleasant taste, which was reported in 5 patients (EPs (R) 7630 group). Conclusion Considering its efficacy and safety profile EPs (R) 7630 may represent a feasible herbal-based treatment option for children with HFMD. Clinical Trial Registration ClinicalTrials.gov, identifier (NCT06353477).
dc.description.sponsorshipAbdi Idot;brahim Foundation
dc.identifier.citationSütçü, M., Kara, M., Yıldız, F., Kılıç, Ö., Tural Kara, T., Akkoc, G., ... & Kara, A. (2024). Hand, foot, and mouth disease: could EPs® 7630 be a treatment option? A prospective randomized open-label multicenter clinical study. Frontiers in Pediatrics, 12, 1274010.
dc.identifier.doi10.3389/fped.2024.1274010
dc.identifier.endpage8
dc.identifier.issn2296-2360
dc.identifier.pmid38832001
dc.identifier.startpage1
dc.identifier.urihttp://dx.doi.org/10.3389/fped.2024.1274010
dc.identifier.urihttps://hdl.handle.net/20.500.12713/6995
dc.identifier.volume12
dc.identifier.wosWOS:001237410600001
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorSütçü, Murat
dc.institutionauthorYıldız, Funda
dc.institutionauthorGül, Doruk
dc.institutionauthoridMurat Sütçü / 0000-0002-2078-9796
dc.institutionauthoridDoruk Gül / 0000-0001-7151-4138
dc.language.isoen
dc.publisherFrontiers media
dc.relation.ispartofFrontiers in pediatrics
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectHand
dc.subjectFoot
dc.subjectMouth Disease
dc.subjectEPs (R) 7630
dc.subjectChildren
dc.subjectHerbal Remedy
dc.subjectClinical Study
dc.titleHand, foot, and mouth disease: could EPs® 7630 be a treatment option? a prospective randomized open-label multicenter clinical study
dc.typeArticle

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