Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea.
Department of Acupuncture & Moxibustion Medicine, Cheonan Korean Medicine Hospital of Daejeon University, Cheonan-si, Republic of Korea.
Trials. 2021 Nov 27;22(1):849. doi: 10.1186/s13063-021-05740-5.
As the population of Korea ages, interest in healthcare has increased. In particular, there is an increasing demand for immune-function improvement to prevent infectious diseases. Phellinus linteus (PL) has previously been shown to exert immune-enhancing and anticancer effects. We aim to evaluate whether PL mycelium extract, cultured from the PL KCTC0399BP strain, can increase immune function, as measured using blood-test indicators. This clinical trial protocol is designed as the main trial and is based on the results of a pilot study.
This clinical trial is a randomized, double-blinded, placebo-controlled trial. Ninety-eight participants are enrolled and randomly divided into two groups: the experimental group (PL 1000 mg) and the control group (placebo). Participants are administered with experimental food or placebo for eight weeks. Blood tests are performed before trial initiation and 8 weeks later, at trial completion. Laboratory evaluation items are as follows: natural killer cell activity, tumor necrosis factor-α, interferon-γ, interleukin (IL)-1β, IL-2, IL-6, IL-12, immunoglobulin (Ig)G1, IgG2, and IgM. We will mainly use the full analysis dataset to statistically analyze the effectiveness of the treatment.
This study evaluates the effects of PL extract on immune function and will contribute to knowledge on the value of PL as an immune-function-boosting functional food.
Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460 . Registered on 12 October 2020.
随着韩国人口老龄化，人们对医疗保健的兴趣日益增加。特别是，人们对提高免疫功能以预防传染病的需求日益增加。此前已经证明，松木层孔菌（PL）具有增强免疫和抗癌作用。我们旨在评估从 PL KCTC0399BP 菌株中培养的 PL 菌丝体提取物是否可以通过血液测试指标来提高免疫功能。本临床试验方案设计为主要试验，基于初步研究结果。
本临床试验为随机、双盲、安慰剂对照试验。共纳入 98 名参与者，并随机分为两组：实验组（PL 1000mg）和对照组（安慰剂）。参与者服用实验性食物或安慰剂 8 周。在试验开始前和 8 周后，即试验完成时进行血液检查。实验室评估项目如下：自然杀伤细胞活性、肿瘤坏死因子-α、干扰素-γ、白细胞介素（IL）-1β、IL-2、IL-6、IL-12、免疫球蛋白（Ig）G1、IgG2 和 IgM。我们将主要使用全分析数据集对治疗效果进行统计分析。
本研究评估了 PL 提取物对免疫功能的影响，将有助于了解 PL 作为增强免疫功能的功能性食品的价值。
韩国临床研究信息服务（CRIS）CRIS-KCT0005460。于 2020 年 10 月 12 日注册。
