Staff View: α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial

α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial

Background: Recurrent Aphthous Stomatitis (RAS) is a common ulcerative disease of the oral mucosa which is characterized by pain, and recurrent lesions in the oral cavity. This condition is quite painful, causing difficulty in eating, speaking and swallowing. Topical medications have been used for t...

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Main Authors:	Vitamia, Cszahreyloren, Iftinan, Ghina Nadhifah, Latarissa, Irma Rahayu, Wilar, Gofarana, Cahyanto, Arief, Mohammed, Ahmed Fouad Abdelwahab, El-Rayyes, Ali, Wathoni, Nasrul
Format:	Article
Published:	Frontiers Media 2024
Subjects:	RS Pharmacy and materia medica
Online Access:	http://eprints.um.edu.my/45615/ https://doi.org/10.3389/fphar.2024.1353503
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spelling	my.um.eprints.456152024-11-06T04:54:41Z http://eprints.um.edu.my/45615/ α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial Vitamia, Cszahreyloren Iftinan, Ghina Nadhifah Latarissa, Irma Rahayu Wilar, Gofarana Cahyanto, Arief Mohammed, Ahmed Fouad Abdelwahab El-Rayyes, Ali Wathoni, Nasrul RS Pharmacy and materia medica Background: Recurrent Aphthous Stomatitis (RAS) is a common ulcerative disease of the oral mucosa which is characterized by pain, and recurrent lesions in the oral cavity. This condition is quite painful, causing difficulty in eating, speaking and swallowing. Topical medications have been used for this condition, but the obstacle in using topical medications is the difficulty of achieving drug effects due to saliva wash out. This problem can be overcome by film hydrogel formulation which can protect the ulcer and reduce the pain to some extent. alpha-mangostin is a xanthone isolated from the rind of the mangosteen fruit. One of the activities of alpha-mangostin is anti-inflammatory effects, which operate through the characteristic mechanism of inhibiting the inflammatory response. This protocol study aims to investigate the efficacy of an alpha-mangostin hydrogel film with a chitosan alginate base for recurrent aphthous stomatitis (RAS) in comparison with a placebo over a period of 7 days. Study design: This is a two-arm, double blinding, randomized controlled trial enrolling patients with RAS. The efficacy test of alpha-mangostin Hydrogel Film will be tested against the placebo. Patients with RAS will be allocated randomly into the two arms and the hydrogel film will be administered for 7 days. The diameter of ulcer and visual analog scale (VAS) score will be used as the primary efficacy endpoint. The outcome measure will be compared between the two arms at the baseline, day 3, day 5, and at the end of 7 days. Discussion: The purpose of this clinical research is to provide scientific evidence on the efficacy of alpha-mangostin hydrogel film with a chitosan alginate basis in treating recurrent aphthous stomatitis. The trial is expected to improve our capacity to scientifically confirm the anti-inflammatory effectiveness of alpha-mangostin compounds in a final formulation that is ready to use. Frontiers Media 2024-02 Article PeerReviewed Vitamia, Cszahreyloren and Iftinan, Ghina Nadhifah and Latarissa, Irma Rahayu and Wilar, Gofarana and Cahyanto, Arief and Mohammed, Ahmed Fouad Abdelwahab and El-Rayyes, Ali and Wathoni, Nasrul (2024) α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial. Frontiers in Pharmacology, 15. p. 1353503. ISSN 1663-9812, DOI https://doi.org/10.3389/fphar.2024.1353503 <https://doi.org/10.3389/fphar.2024.1353503>. https://doi.org/10.3389/fphar.2024.1353503 10.3389/fphar.2024.1353503
institution	Universiti Malaya
building	UM Library
collection	Institutional Repository
continent	Asia
country	Malaysia
content_provider	Universiti Malaya
content_source	UM Research Repository
url_provider	http://eprints.um.edu.my/
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica Vitamia, Cszahreyloren Iftinan, Ghina Nadhifah Latarissa, Irma Rahayu Wilar, Gofarana Cahyanto, Arief Mohammed, Ahmed Fouad Abdelwahab El-Rayyes, Ali Wathoni, Nasrul α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
description	Background: Recurrent Aphthous Stomatitis (RAS) is a common ulcerative disease of the oral mucosa which is characterized by pain, and recurrent lesions in the oral cavity. This condition is quite painful, causing difficulty in eating, speaking and swallowing. Topical medications have been used for this condition, but the obstacle in using topical medications is the difficulty of achieving drug effects due to saliva wash out. This problem can be overcome by film hydrogel formulation which can protect the ulcer and reduce the pain to some extent. alpha-mangostin is a xanthone isolated from the rind of the mangosteen fruit. One of the activities of alpha-mangostin is anti-inflammatory effects, which operate through the characteristic mechanism of inhibiting the inflammatory response. This protocol study aims to investigate the efficacy of an alpha-mangostin hydrogel film with a chitosan alginate base for recurrent aphthous stomatitis (RAS) in comparison with a placebo over a period of 7 days. Study design: This is a two-arm, double blinding, randomized controlled trial enrolling patients with RAS. The efficacy test of alpha-mangostin Hydrogel Film will be tested against the placebo. Patients with RAS will be allocated randomly into the two arms and the hydrogel film will be administered for 7 days. The diameter of ulcer and visual analog scale (VAS) score will be used as the primary efficacy endpoint. The outcome measure will be compared between the two arms at the baseline, day 3, day 5, and at the end of 7 days. Discussion: The purpose of this clinical research is to provide scientific evidence on the efficacy of alpha-mangostin hydrogel film with a chitosan alginate basis in treating recurrent aphthous stomatitis. The trial is expected to improve our capacity to scientifically confirm the anti-inflammatory effectiveness of alpha-mangostin compounds in a final formulation that is ready to use.
format	Article
author	Vitamia, Cszahreyloren Iftinan, Ghina Nadhifah Latarissa, Irma Rahayu Wilar, Gofarana Cahyanto, Arief Mohammed, Ahmed Fouad Abdelwahab El-Rayyes, Ali Wathoni, Nasrul
author_facet	Vitamia, Cszahreyloren Iftinan, Ghina Nadhifah Latarissa, Irma Rahayu Wilar, Gofarana Cahyanto, Arief Mohammed, Ahmed Fouad Abdelwahab El-Rayyes, Ali Wathoni, Nasrul
author_sort	Vitamia, Cszahreyloren
title	α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
title_short	α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
title_full	α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
title_fullStr	α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
title_full_unstemmed	α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial
title_sort	α-mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (ras) treatment: study protocol for double-blind randomized controlled trial
publisher	Frontiers Media
publishDate	2024
url	http://eprints.um.edu.my/45615/ https://doi.org/10.3389/fphar.2024.1353503
_version_	1816130426939375616
score	13.223943

α-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial

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