Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Jan 25;19(1):18.
doi: 10.1186/s13020-024-00880-7.

Zhuifeng Tougu capsules in the treatment of knee osteoarthritis (cold dampness obstruction syndrome): a randomized, double blind, multicenter clinical study

Longmei Zhao #  1 , Shasha Zhou #  2   3 , SiWei Wang #  4   5 , Rui Wu  6 , Qingliang Meng  7 , Zhenbin Li  8 , Jiangyun Peng  9 , Ying Liu  10 , Min Lu  11 , Ming Li  12 , Caifeng Zhu  13 , Yue Sun  14 , Yanlin He  3 , Yue Jin  4   5 , Jingyue Gao  4   5 , Shumin Zhang  15 , Peihao Li  16 , Rongjun Liao  16 , Wei Liu  17   18 , Guoming Zhang  19
Affiliations

Zhuifeng Tougu capsules in the treatment of knee osteoarthritis (cold dampness obstruction syndrome): a randomized, double blind, multicenter clinical study

Longmei Zhao et al. Chin Med. .

Abstract

Background: In Traditional Chinese Medicine (TCM) theory, cold dampness obstruction is one of the common syndromes of osteoarthritis. Therefore, in clinical practice, the main treatment methods are to dispel wind, remove dampness, and dissipate cold, used to treat knee osteoarthritis (KOA). This report describes a mulitercenter clinical study to assess Zhuifeng Tougu Capsule's efficacy and safety in the treatment of patients who are cold dampness obstruction syndrome in KOA, and to provide evidence-based medical for the rational use of Zhuifeng Tougu Capsules in clinical practice.

Methods: This randomized, parallel group controlled, double-blind, double dummy trial will include a total of 215 KOA patients who meet the study criteria. 215 patients underwent 1:1 randomisation, with 107 cases assigned the experimental group (Zhuifeng Tougu Capsules + Glucosamine Sulfate Capsules Simulator) and 108 assigned the control group (Glucosamine Sulfate Capsules + Zhuifeng Tougu Capsules Simulator). After enrolment, patients received 12 weeks of treatment. The main efficacy measure is the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) pain score. Visual analogue scale (VAS) pain score, Self-condition assessment VAS score, WOMAC KOA score, TCM syndrome score and TCM syndrome efficacy, ESR level, CRP level, suprapatellar bursa effusion depth, use of rescue drugs, and safety indicators are secondary efficacy indicators.

Results: Compared with before treatment, WOMAC pain score, VAS pain score, Self-condition assessment VAS score, WOMAC KOA score, and TCM syndrome score decreased significantly in both groups (P < 0.01). Also, the experimental group showed significant differences in the above indicators compared to control (P < 0.01). However, after treatment, no significant differences were showed in the ESR level, CRP level, and suprapatellar bursa effusion depth between the two groups (P > 0.05). No any serious adverse effects showed in the experimental group and control group.

Conclusions: Zhuifeng Tougu Capsules can effectively improve knee joint function and significantly alleviate the pain of KOA.

Trial registration: Clinical trial registration was completed with the China Clinical Trial Registration Center for this research protocol (No. ChiCTR2000028750) on January 2, 2020.

Keywords: Chinese herbal medicine formula; Clinical trial; Knee osteoarthritis; Randomized controlled trial.

PubMed Disclaimer

Conflict of interest statement

This research was jointly funded by the government unit Changsha Science and Technology Bureau and Tiandi Hengyi Pharmaceutical Co., Ltd. All authors declare that the study was conducted without any commercial or financial relationships that could be interpreted as potential conflicts of interest.

Figures

Fig. 1
Fig. 1
Systematic illustration of study design
Fig. 2
Fig. 2
Changes in WOMAC pain scores between two groups. A. (FAS) B. (PPS)
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Ho J, Mak C, Sharma V, To K, Khan W. Mendelian randomization studies of lifestyle-related risk factors for osteoarthritis a prisma review and meta-analysis. Int J Mol Sci. 2022;23(19):11906. doi: 10.3390/ijms231911906. - DOI - PMC - PubMed
    1. Liu T, Xu C, Driban JB, McAlindon T, Eaton CB, Lu B. Excessive alcohol consumption and the risk of knee osteoarthritis: a prospective study from the osteoarthritis initiative. Osteoarthritis Cartilage. 2022;30(5):697–701. doi: 10.1016/j.joca.2022.01.011. - DOI - PMC - PubMed
    1. Brandt KD, Dieppe P, Radin E. Etiopathogenesis of osteoarthritis. Med Clin North Am. 2009;93(1):1–24. doi: 10.1016/j.mcna.2008.08.009. - DOI - PubMed
    1. Yao Q, Wu X, Tao C, Gong W, Chen M, Qu M, et al. Osteoarthritis: pathogenic signaling pathways and therapeutic targets. Signal Transduct Target Ther. 2023;8(1):56. doi: 10.1038/s41392-023-01330-w. - DOI - PMC - PubMed
    1. Rodríguez-Merchán EC. Intraarticular injections of mesenchymal stem cells in knee osteoarthritis: a review of their current molecular mechanisms of action and their efficacy. Int J Mol Sci. 2022;23(23):14953. doi: 10.3390/ijms232314953. - DOI - PMC - PubMed