A clinical pilot study to evaluate the efficacy of oral intake of phellinus linteus (sanghuang) extract on knee joint and articular cartilage: Study protocol clinical trial (SPIRIT Compliant)

Medicine (Baltimore). 2020 Feb;99(8):e18912. doi: 10.1097/MD.0000000000018912.


Background: Knee osteoarthritis (KOA) is the most common form of degenerative arthritis. We used Phellinus linteus (PL), which has been well-known anti-inflammatory function. In this study, we will evaluate if PL extract improves symptoms with KOA.

Methods: This study will be an 8-week single-center randomized controlled double-blind clinical trial. Total of 24 subjects with KOA will be enrolled and they will be divided into 3 groups, PL 1,000 mg, PL 1,500 mg and placebo. Subjects will be followed up every 4 weeks with efficacy and safety at the 2nd and 3rd visits. All subjects should maintain a dosage schedule for this protocol. The primary outcome will be assessed with the Korean version of the Western Ontario and McMasters Universities. And the secondary outcomes will be measured using the visual analog scale, quality of life scale (EQ-5D-3L), ESR, C-reactive protein, and C-telopeptide of type-II collagen. Statistical analysis will be performed on the principle of full analysis set.

Discussion: This study has inclusion and exclusion criteria and a well-controlled intervention. This clinical trial is the first step to assess the efficacy and safety of PL in patients with KOA. This study will make an important contribution to the literature and aid follow-up research into the use of PL in KOA.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Blood Sedimentation / drug effects
  • C-Reactive Protein / drug effects
  • Cartilage, Articular / drug effects*
  • Collagen Type I / drug effects
  • Humans
  • Knee Joint / drug effects*
  • Middle Aged
  • Osteoarthritis, Knee / blood
  • Osteoarthritis, Knee / drug therapy*
  • Osteoarthritis, Knee / pathology
  • Peptides / drug effects
  • Phellinus
  • Placebos / administration & dosage
  • Plant Extracts / administration & dosage*
  • Plant Extracts / therapeutic use
  • Prospective Studies
  • Quality of Life
  • Republic of Korea / epidemiology
  • Treatment Outcome


  • Collagen Type I
  • Peptides
  • Phellinus linteus extract
  • Placebos
  • Plant Extracts
  • collagen type I trimeric cross-linked peptide
  • C-Reactive Protein