UnknownPhase 2

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

Indonesia48 participantsStarted 2023-12-04

Plain-language 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.

Who can participate

Age range

18 Years – 59 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-59years * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Ulcer Size

Timeframe: 7 days

Pain Visual Analogue Scale (VAS Score)

Timeframe: 7 days

Trial details

NCT IDNCT06039774

SponsorUniversitas Padjadjaran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06-28

Contact for this trial

Cszahreyloren Vitamia, M.Si

+6282120176639 cszahreyloren20001@mail.unpad.ac.id

View on ClinicalTrials.gov More Recurrent Aphthous Stomatitis trials