A Clinical Investigation Into the Dermal Application of L. Rhinocerus TM02(r) Water Extract for Mouth Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Pain Assessment
研究概览
简要总结
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.
详细描述
Project overview Lignosus rhinocerus, commonly known as tiger milk mushroom (TMM), is a medicinal fungus native to Southeast Asia. Traditionally, it has been utilized for various health conditions, including wound healing. Recent studies have highlighted its anti-inflammatory, antimicrobial, and immunomodulatory properties, particularly in its cultivated form, TM02® .
Aphthous ulcers, or recurrent aphthous stomatitis (RAS), are common, painful lesions of the oral mucosa affecting a significant portion of the adult population. Current treatments primarily involve topical corticosteroids, which may have side effects with prolonged use. Given the traditional use of L. rhinocerus in wound care, this study aims to evaluate the efficacy of TM02® gel in treating minor oral aphthous ulcers.
Hypothesis and general objective Hypothesis: L. rhinocerus cultivar TM02® gel accelerates the healing process of minor oral aphthous ulcers compared to standard treatments.
Primary Objective: To assess the efficacy of L. rhinocerus TM02® gel in promoting the healing of minor oral aphthous ulcers.
Methodology Mushroom Material and Gel Formulation Lignosus rhinocerus TM02® freeze-dried sclerotia powder (TM02®) was obtained from LiGNO Biotech Sdn. Bhd. (Selangor, Malaysia). This commercially available product is officially registered under the Protection of New Plant Varieties Act (NPVA), Malaysia (Registration No.: PVBT010/11). The authenticity of TM02® was confirmed via polymerase chain reaction (PCR) amplification and sequencing of the internal transcribed spacer (ITS) region. To extract its bioactive compounds, the sclerotia powder underwent cold water extraction at a 1:20 ratio of powder to distilled water, followed by centrifugation and freeze-drying. The resulting extract, referred to as xLr®, was then formulated into an oral gel by incorporating it with xanthan gum as a thickening agent and 0.5% sodium benzoate as a preservative. The final gel formulation (containing 25% xLr®) was stored at room temperature until further use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Base formulation
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.
干预措施: Placebo (Other)
xLr oral gel
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.
干预措施: xLr oral gel (Other)
Kanolone Oral Base Paste
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.
干预措施: Kanolone (Drug)
结局指标
主要结局
Pain Assessment
时间窗: Daily assessments on Days 1 through 7 during the intervention
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.
Wound Epithelialization
时间窗: Assessments on Days 3, 5, and 7 during the intervention
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.
Ulcer size
时间窗: Days 1, 3, 5, and 7 during the intervention
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
次要结局
未报告次要终点
研究者
Yeannie Yap
Senior Lecturer
Mahsa University