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Pilot Clinical Study Testing Tiger Milk Mushroom Gel (Lignosus Rhinocerus TM02®) for Treating Mouth Ulcers

NCT06969495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2025-05-15

No results posted yet for this study

Summary

This is a pilot clinical trial study to investigate the wound healing capability of a TM02® water extract formulation in patient with minor oral ulcers (2 - 5 mm in size). The sclerotium of L. rhinocerus is traditionally used as a health tonic or treatment regime for asthma, bronchitis, various cancer ailments as well as discomforts caused by fright, fever, cough, vomiting, and injury. Further on to that, this mushroom has also been traditionally used by the local Malay and Chinese communities to treat wounds, although it is yet to be scientifically validated. Its sclerotia are being consumed in the form of decoction, in a betel quid, and other preparation method where the sclerotium is pounded with raw rice, infused, and subsequently taken as a drink. There is also a practice of biting/chewing of the sclerotium by local indigenous communities during their journeys in the wild.

Conditions

  • Mouth Ulcer

Interventions

OTHER

xLr oral gel

25% of Cold water extract of Tiger milk mushroom sclerotial powder in a gel form containing xanthan gum as a thickening agent and 0.5% sodium benzoate as a preservative.

OTHER

Placebo

oral gel base formulation without the Lignosus rhinocerus extract

DRUG

Kanolone

Kanolone Oral Base Paste (Triamcinolone acetonide 0.1%)

Sponsors & Collaborators

  • Mahsa University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2023-11-30
Completion
2024-02-23

Countries

  • Malaysia

Study Locations

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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 NCT06969495 on ClinicalTrials.gov