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α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) (AM-RAS)

Primary Purpose

Recurrent Aphthous Stomatitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
α-Mangostin Hydrogel Film With Chitosan Alginate Base
Placebo
Sponsored by
Universitas Padjadjaran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Aphthous Stomatitis

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 18-40 years Healthy subjects without mouth diseases Not using drugs for RAS therapy Not involved with other clinical trials Willing to participate Exclusion Criteria: Have a mouth disease Have other serious illnesses, including arrhythmia, uncontrolled hypertension, diabetes, hepatitis, and kidney failure pregnant or lactating women, and women who wish to become pregnant during the study period poor oral hygiene that requires treatment chronic diseases requiring treatment with antibiotics, hormones, nonsteroidal anti-inflammatory drugs, immunosuppressants, immune enhancers, cytotoxic drugs, or cell cycle agents that affect the oral mucosa mental illness or limited mental capacities

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    α-Mangostin Hydrogel Film With Chitosan Alginate Base

    Placebo

    Arm Description

    Subjects will receive α-Mangostin Hydrogel Film With Chitosan Alginate Base in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep, subjects will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day

    Subjects will receive Hydrogel Film With Chitosan Alginate Base without an active compound in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep and will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day

    Outcomes

    Primary Outcome Measures

    Ulcer Size
    The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.
    Pain Visual Analogue Scale (VAS Score)
    Determine the effect of α-Mangostin for reducing pain intensity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (the worst pain ever felt / imagined by the subject). After being explained, subjects will be asked to place a mark on the line to rate their current level of pain. The investigators will measure the distance of the mark from 0 end point using a ruler and record the number up to 1 decimal point. VAS scores will be measured and recorded twice, i.e. day 1 and day 7.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 4, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Universitas Padjadjaran
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06039774
    Brief Title
    α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS)
    Acronym
    AM-RAS
    Official Title
    Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 12, 2023 (Anticipated)
    Primary Completion Date
    December 22, 2023 (Anticipated)
    Study Completion Date
    March 12, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitas Padjadjaran

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Recurrent Aphthous Stomatitis (RAS) is experienced by almost everyone and appears suddenly. Even though the risk of death due to the condition is small, its presence can make a person feel uncomfortable eating, drinking, and talking so there will be a decrease in the quality of a person's life in their daily lives. Recently, α-Mangostin (α-M) from mangosteen rind (Garcinia mangostana L) has been shown its effect to reduce oral mucosal sores on RAS in preclinical studies in rats. Therefore, research is needed to prove the benefits (efficacy) and safety of therapy in the form of a hydrogel film patch/plaster film with a chitosan alginate base as a carrier for α-Mangostin for the treatment of RAS patients.
    Detailed Description
    Topical medications are the primary option for addressing RAS (Recurrent Aphthous Stomatitis) due to their affordability, effectiveness, and safety. These treatments encompass various forms such as mouthwashes, aerosols, lozenges, and ointments, available in liquid, solid, and semi-solid preparations. However, employing topical drugs faces challenges related to achieving desired therapeutic outcomes. A significant hurdle is the hindered delivery of drugs to the oral mucosa, often referred to as "saliva wash out," which leads to the removal and rinsing away of the drug from the mucosal surface. Efforts in developing drug delivery systems for RAS treatment are directed towards achieving several goals. These include prolonging the time drugs remain effective at the site of the ulcer, ensuring the release of adequate drug concentrations to the ulcer, and alleviating pain. Addressing this issue involves the creation of film formulations that can serve as a protective layer for the ulcer. Such formulations act as barriers against external stimuli while offering a certain degree of pain relief. An indigenous plant of Indonesia that has found application in traditional healing is the mangostin peel (Garcinia mangostana L.). α-mangostin, extracted from the rind of the mangosteen, has been employed in traditional medicine. Among its attributes, α-mangostin exhibits anti-inflammatory properties, functioning effectively by impeding the inflammatory response. This characteristic positions α-mangostin as a viable alternative compound for addressing RAS management. To facilitate the delivery of α-mangostin, a combination of two mucoadhesive polymers, specifically sodium alginate and chitosan, is utilized as a drug delivery system. In earlier studies, the development and analysis of a hydrogel film containing α-mangostin, utilizing a chitosan-alginate foundation, were conducted to explore their potential for treating RAS in vivo. These experiments involved testing on white Wistar rats, resulting in a remarkable 93% healing rate by the seventh day. Consequently, additional research focusing on the chitosan-alginate based α-mangostin hydrogel film will progress to clinical and safety trials. The objective is to establish its effectiveness among RAS patients and assess its suitability as a readily applicable treatment option.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Recurrent Aphthous Stomatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    α-Mangostin Hydrogel Film With Chitosan Alginate Base
    Arm Type
    Experimental
    Arm Description
    Subjects will receive α-Mangostin Hydrogel Film With Chitosan Alginate Base in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep, subjects will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects will receive Hydrogel Film With Chitosan Alginate Base without an active compound in the form of a patch. Subjects will apply the patch once a day after breakfast or at night before sleep and will be told to avoid drinking or eating for 1 hour after using the hydrogel film because these activities can remove the hydrogel film. Ulcer size and VAS score will recorded on the first day (baseline), the 3rd day, the 5th day, and the 7th day
    Intervention Type
    Drug
    Intervention Name(s)
    α-Mangostin Hydrogel Film With Chitosan Alginate Base
    Intervention Description
    Patients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo
    Primary Outcome Measure Information:
    Title
    Ulcer Size
    Description
    The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.
    Time Frame
    7 days
    Title
    Pain Visual Analogue Scale (VAS Score)
    Description
    Determine the effect of α-Mangostin for reducing pain intensity. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (the worst pain ever felt / imagined by the subject). After being explained, subjects will be asked to place a mark on the line to rate their current level of pain. The investigators will measure the distance of the mark from 0 end point using a ruler and record the number up to 1 decimal point. VAS scores will be measured and recorded twice, i.e. day 1 and day 7.
    Time Frame
    7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-40 years Healthy subjects without mouth diseases Not using drugs for RAS therapy Not involved with other clinical trials Willing to participate Exclusion Criteria: Have a mouth disease Have other serious illnesses, including arrhythmia, uncontrolled hypertension, diabetes, hepatitis, and kidney failure pregnant or lactating women, and women who wish to become pregnant during the study period poor oral hygiene that requires treatment chronic diseases requiring treatment with antibiotics, hormones, nonsteroidal anti-inflammatory drugs, immunosuppressants, immune enhancers, cytotoxic drugs, or cell cycle agents that affect the oral mucosa mental illness or limited mental capacities
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cszahreyloren Vitamia, M.Si
    Phone
    +6282120176639
    Email
    cszahreyloren20001@mail.unpad.ac.id
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nasrul Wathoni, Ph.D
    Phone
    +6281313142421
    Email
    nasrul@unpad.ac.id
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Indah Suasani Wahyuni, drg.
    Organizational Affiliation
    Faculty of Dentistry Universitas Padjadjaran Bandung
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS)

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