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

NCT06039774 | Unknown Phase 2 DMC

• 1 other identifier: Pharm-202309.01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Aphthous Stomatitis

Outcome Measures

Primary Outcomes (2)

• Ulcer Size

  The diameter of the ulcer will be measured twice (day 1 and day 7) using a ruler.

  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.

  7 days

Study Arms (2)

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

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

Drug: Placebo

Interventions

α-Mangostin Hydrogel Film With Chitosan Alginate Base DRUG

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

α-Mangostin Hydrogel Film With Chitosan Alginate Base

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-59years
• Healthy subjects without mouth diseases
• Not using drugs for RAS therapy
• Not involved with other clinical trials
• Willing to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Padjadjaran University Dental and Oral Hospital

Bandung, West Java, 40132, Indonesia

RECRUITING

Related Publications (1)

• 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.

  PMID: 38434698 DERIVED

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Indah Suasani Wahyuni, drg.

  Faculty of Dentistry Universitas Padjadjaran Bandung

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cszahreyloren Vitamia, M.Si

CONTACT

+6282120176639; cszahreyloren20001@mail.unpad.ac.id

Nasrul Wathoni, Ph.D

CONTACT

+6281313142421; nasrul@unpad.ac.id

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 15, 2023
• Study Start: December 4, 2023
• Primary Completion: June 28, 2024
• Study Completion: December 20, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-09

Locations

ID (1)