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Randomized Controlled Trial
. 2020 Jul 10;99(28):e20907.
doi: 10.1097/MD.0000000000020907.

A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild osteoarthritis

Donghun Lee  1 , Seok Jung Kim  2 , Hocheol Kim  3
Affiliations
Randomized Controlled Trial

A 12 week, randomized, double-blind, placebo-controlled clinical trial for the evaluation of the efficacy and safety of HT083 on mild osteoarthritis

Donghun Lee et al. Medicine (Baltimore). .

Abstract

Background: The 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.

Methods: This 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.

Discussion: This trial is expected to provide clinical evidence on the effectiveness and the safety of HT083 as a natural treatment for mild OA.

Trial registration: Korean Clinical Research Information Service (CRIS) number KCT0004925 Registered on 2020.04.16.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flow diagram of the trial.
See this image and copyright information in PMC

References

    1. Chien TY, Huang SK, Lee CJ, et al. Antinociceptive and anti-inflammatory effects of zerumbone against mono-iodoacetate-induced arthritis. Int J Mol Sc 2016;17:1–1. - PMC - PubMed
    1. O’Brien M, Philpott HT, McDougall JJ. Understanding osteoarthritis pain through animal models. Clin Exp Rheumatol 2017;35:S47–52. - PubMed
    1. Lee D, Ju MK, Kim H. Commiphora Extract Mixture Ameliorates Monosodium Iodoacetate-Induced Osteoarthritis. Nutrients 2020;12:E1477. - PMC - PubMed
    1. Zhang W, Dai S. Mechanisms involved in the therapeutic effects of Paeonia lactiflora Pallas in rheumatoid arthritis. Int Immunopharmacol 2012;14:27–31. - PubMed
    1. Shulan S, Yongging H, Yanyan W, et al. Evaluation of the anti-inflammatory and analgesic properties ofindividual and combined extracts from Commiphora myrrha, and Boswellia carterii. J Ethnopharm 2012;139:649–55. - PubMed

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