Recurrent Aphthous StomatitisPhase 2AM-RASNCT06039774
α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS)
A Phase 2 study testing α-Mangostin Hydrogel Film With Chitosan Alginate Base in people with Recurrent Aphthous Stomatitis, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- α-Mangostin Hydrogel Film With Chitosan Alginate Base
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Dec 2023to 20 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-59years
- Healthy subjects without mouth diseases
- Not using drugs for RAS therapy
- Not involved with other clinical trials
- Willing to participate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Padjadjaran University Dental and Oral Hospital
Bandung, West Java, 40132
Indah Suasani, Dr. drg., 082116955033
About this study
Official title: Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment
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.
Read the 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.
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- α-Mangostin Hydrogel Film With Chitosan Alginate Base, Placebo
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α-Mangostin Hydrogel Film With Chitosan Alginate BaseDrug
Patients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| α-Mangostin Hydrogel Film With Chitosan Alginate Base | Experimental | 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 Receives: Drug: α-Mangostin Hydrogel Film With Chitosan Alginate Base |
| Placebo | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulcer Size
The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.
Measured: 7 days
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start4 Dec 2023 (estimated)
- Primary completion28 Jun 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Indah Suasani Wahyuni, drg., Principal investigator, Faculty of Dentistry Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039774
- Sponsor's protocol ID
- Pharm-202309.01
- Acronym
- AM-RAS
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vitamia C, Iftinan GN, Latarissa IR, Wilar G, Cahyanto A, Mohammed AFA, El-Rayyes A, Wathoni N. alpha-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial. Front Pharmacol. 2024 Feb 16;15:1353503. doi: 10.3389/fphar.2024.1353503. eCollection 2024.
PubMed 38434698
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment
- ClinicalTrials.gov ID
- NCT06039774
- Acronym / sponsor ID
- AM-RAS / Pharm-202309.01
- Conditions
- Recurrent Aphthous Stomatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 4 Dec 2023 (estimated)
- Primary completion
- 28 Jun 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| α-Mangostin Hydrogel Film With Chitosan Alginate Base | Experimental | Drug: α-Mangostin Hydrogel Film With Chitosan Alginate BaseSubjects 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 |
| Placebo | Placebo comparator | Drug: PlaceboSubjects 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 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-59years
- Healthy subjects without mouth diseases
- Not using drugs for RAS therapy
- Not involved with other clinical trials
- Willing to participate
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| α-Mangostin Hydrogel Film With Chitosan Alginate BasePatients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days | Drug | α-Mangostin Hydrogel Film With Chitosan Alginate Base |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Ulcer Size
Time frame: 7 days
The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.
Pain Visual Analogue Scale (VAS Score)
Time frame: 7 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2023.
- Derived from this study: PubMed 38434698Vitamia C, Iftinan GN, Latarissa IR, Wilar G, Cahyanto A, Mohammed AFA, El-Rayyes A, Wathoni N. alpha-Mangostin hydrogel film with chitosan alginate base for recurrent aphthous stomatitis (RAS) treatment: study protocol for double-blind randomized controlled trial. Front Pharmacol. 2024 Feb 16;15:1353503. doi: 10.3389/fphar.2024.1353503. eCollection 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indah Suasani Wahyuni, drg. principal investigator
Faculty of Dentistry Universitas Padjadjaran Bandung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing α-Mangostin Hydrogel Film With Chitosan Alginate Base in people with Recurrent Aphthous Stomatitis, run by Universitas Padjadjaran at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cszahreyloren Vitamia, M.Si (+6282120176639, cszahreyloren20001@mail.unpad.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer Size (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06039774, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023.