• Donghun Lee, Seok Jung Kim, and Hocheol Kim.
• Department of Herbal Pharmacology, College of Korean Medicine, Gachon University, Seongnam.
• Medicine (Baltimore). 2020 Jul 10; 99 (28): e20907.

BackgroundThe increasing prevalence of osteoarthritis among the old population worldwide is a great concern. Two of the biggest complaints of OA patients are joint pain and inflammation. Currently, people are relying on non-steroidal anti-inflammatory drugs (NSAIDs) and steroids to control pain and inflammation. However, long-term use of these pharmaceutical drugs has negative health consequences in the elderly, including gastro-intestinal, respiratory, and renal diseases. Natural products are receiving more attention than ever as alternative treatments against OA for their efficacies and safety. The root of Paeonia lactiflora Pal and the gum resin of Commiphora myrrha have been used as analgesics and anti-inflammatory agents since ancient time. A new herbal formula composed of P. lactiflora root and C. myrrha gum resin extracts, known as HT083, has shown promising antinociceptive and anti-inflammatory effects in a rodent model of OA. We design this study to investigate the safety and the efficacy of HT083 to prevent OA in patients with mild OA.MethodsThis is a randomized, double-blind, and placebo-controlled study. A total of 100 eligible participants will be divided into two groups and will be given HT083 and a placebo for 12 weeks in 1:1 ratio. Treatment results will be assessed using a visual analog scale (VAS), Korean-Short Form health survey-36 score (SF-36), personal evaluation, and laboratory analysis.DiscussionThis trial is expected to provide clinical evidence on the effectiveness and the safety of HT083 as a natural treatment for mild OA.Trial RegistrationKorean Clinical Research Information Service (CRIS) number KCT0004925 Registered on 2020.04.16.

63 keywords...

hide…