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

NCT06969495 | Completed DMC

• 1 other identifier: RP185_05/22
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tiger Milk Mushroom; Mouth ulcers; Wound healing; Natural remedies

Outcome Measures

Primary Outcomes (3)

• Pain Assessment

  Pain levels were assessed daily over a seven-day period using the Visual Analog Scale (VAS), where 0 represented no pain and 10 indicated the worst possible pain.

  Daily assessments on Days 1 through 7 during the intervention

• Wound Epithelialization

  Wound epithelialisation was evaluated on Days 3, 5, and 7 by applying a 3% hydrogen peroxide (H₂O₂) solution to the ulcer site. The formation of bubbles indicated incomplete epithelialisation, while the absence of bubbles signified complete epithelialisation, offering a reliable and consistent measure of the healing process.

  Assessments on Days 3, 5, and 7 during the intervention

• Ulcer size

  Ulcer size was measured on Days 1, 3, 5, and 7 using a transparent grid overlay. Each square on the grid represented a surface area of 4 mm². The total ulcer area (mm²) was determined by counting the number of squares within the ulcer's outline, providing an objective assessment of wound size over time

  Days 1, 3, 5, and 7 during the intervention

Study Arms (3)

Base formulation

PLACEBO COMPARATOR

Participants will receive an oral gel base formulation without the Lignosus rhinocerus extract. The placebo gel will be applied to the mouth ulcer three times daily for seven days.

Other: Placebo

xLr oral gel

EXPERIMENTAL

Participants will receive an oral gel containing 25% Lignosus rhinocerus TM02® cold water extract (xLr®). The gel will be applied to the mouth ulcer three times daily for seven days.

Other: xLr oral gel

Kanolone Oral Base Paste

ACTIVE COMPARATOR

Participants will receive Kanolone Oral Base Paste (Triamcinolone acetonide 0.1%), a standard topical corticosteroid treatment for aphthous ulcers. The paste will be applied to the mouth ulcer three times daily for seven days.

Drug: Kanolone

Interventions

xLr oral gel OTHER

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.

Also known as: TM02 gel

xLr oral gel

Placebo OTHER

oral gel base formulation without the Lignosus rhinocerus extract

Also known as: Vehicle ctrl

Base formulation

Kanolone DRUG

Kanolone Oral Base Paste (Triamcinolone acetonide 0.1%)

Also known as: Positive ctrl

Kanolone Oral Base Paste

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants aged between 20 and 50 years
• No history of systemic diseases such as leukemia, hemophilia, uncontrolled diabetes mellitus, or serious cardiac conditions
• Presence of minor oral aphthous ulcers ranging from 2 to 5 mm in size
• No use of medications, including topical steroids or mouthwashes, for at least 3 months prior to the study
• Willingness to provide written informed consent and adhere to the study protocol.

You may not qualify if:

• Pregnant or lactating women; Known allergies to any components of the study formulations
• Any condition that, in the opinion of the investigator, may interfere with the study objectives or participant safety.

Sponsors & Collaborators

• Mahsa University: lead

Study Sites (1)

MAHSA University Dental Clinic

Jenjarum, Selangor, 42610, Malaysia

Location

MeSH Terms

Conditions

Oral Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 14, 2025
• Study Start: February 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: February 23, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)