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

• Status: Recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitas Padjadjaran
• Treatments: Chitosan

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