Clinical trial NCT06039774: α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS)
Official title: Clinical Efficacy of α-Mangostin Hydrogel Film With Chitosan Alginate Base for Recurrent Aphthous Stomatitis (RAS) Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Aphthous Stomatitis
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ulcer Size
timeFrame: 7 days
measure: Pain Visual Analogue Scale (VAS Score)
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Padjadjaran University Dental and Oral Hospital
state: Jawa Barat
Study officials:
affiliation: Faculty of Dentistry Universitas Padjadjaran Bandung
name: Indah Suasani Wahyuni, drg.
role: PRINCIPAL_INVESTIGATOR
References: