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

NCT06039774 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-11-15

No results posted yet for this study

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.

Conditions

  • Recurrent Aphthous Stomatitis

Interventions

DRUG

α-Mangostin Hydrogel Film With Chitosan Alginate Base

Patients will apply α-Mangostin Hydrogel Film With Chitosan Alginate Base once a day for 7 days

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Universitas Padjadjaran

    lead OTHER

Principal Investigators

  • Indah Suasani Wahyuni, drg. · Faculty of Dentistry Universitas Padjadjaran Bandung

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-04
Primary Completion
2024-06-28
Completion
2024-12-20

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06039774 on ClinicalTrials.gov