Pilot Clinical Study Testing Tiger Milk Mushroom Gel (Lignosus Rhinocerus TM02®) for Treating Mou… (NCT06969495) | Clinical Trial Compass
CompletedNot Applicable
Pilot Clinical Study Testing Tiger Milk Mushroom Gel (Lignosus Rhinocerus TM02®) for Treating Mouth Ulcers
Malaysia21 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Age range
20 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Assessment
Timeframe: Daily assessments on Days 1 through 7 during the intervention
2
Wound Epithelialization
Timeframe: Assessments on Days 3, 5, and 7 during the intervention
3
Ulcer size
Timeframe: Days 1, 3, 5, and 7 during the intervention