Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial.
Background: 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...
| Publicado en: | Trials Vol. 22; no. 1; pp. 1 - 8 |
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| Autores principales: | , , , |
| Formato: | Journal Article |
| Publicado: |
BioMed Central
11/27/2021
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=153818458&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 153818458 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17456215 38OC jtl: Trials issn: 17456215 maglogo: N pubinfo: dt: 11/27/2021 vid: 22 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 153818458 153818458 NLM34838112 10.1186/s13063-021-05740-5 NLM34838112 153818458 ppf: 1 ppct: 7 formats: tig: atl: Clinical trial to analyze the effects of oral intake of Phellinus linteus (sanghuang) extract on immune function: a study protocol for a randomized, double-blind controlled trial. aug: au: Ku, Yong Ho Lee, Hyun Ryu, Hwa Yeon Kang, Jae Hui affil: Department of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Daejeon University, Daejeon, Republic of Korea sug: ab: Background: 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.Methods: 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.Discussion: 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.Trial Registration: Clinical Research Information Service (CRIS) of Korea CRIS-KCT0005460 . Registered on 12 October 2020. pubtype: Academic Journal doctype: Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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