Objective To investigate the clinical efficacy of combining Duhuo Jisheng Decoction Formula Granules with intra⁃articular ozone injection for treating knee osteoarthritis (KOA). Methods A total of 60 KOA patients were randomly assigned to treatment group or control group, with 30 cases in each group. The control group was orally administrated Glucosamine Hydrochloride Capsules, whereas the treatment group received Duhuo Jisheng Decoction Formula Granules combined with intra⁃articular ozone injection. The course of treatment was 4 weeks, and the follow⁃up was 2 months. After 4 weeks of treatment, the clinical efficacy of both groups was evaluated. Pre⁃treatment, 4⁃week post⁃treatment, and 2⁃month follow⁃up Visual Analogue Scale (VAS) score for pain, Lysholm knee joint functional score, and inflammatory indices including erythrocyte sedimentation rate (ESR), C⁃reactive protein (CRP) level, and tumor necrosis factor α (TNF⁃α) level, as well as adverse reactions during treatment were compared between patients of the two groups. Results The total effective rate of treatment in the treatment group was higher than that in the control group (P<0.05). After 4 weeks of treatment and 2 months of follow⁃up, the VAS score for pain and ESR, CRP level, and TNF⁃α level in the two groups were lower than those before treatment, and the Lysholm knee joint functional score was higher than that before treatment, and the above indexes in the treatment group were superior to those in the control group (P<0.05). There was no statistically significant difference in the total incidence rate of adverse reactions between the two groups during treatment (P>0.05). Conclusions Duhuo Jisheng Decoction Formula Granules combined with intra⁃articular ozone injection can effectively relieve pain symptom, improve knee joint function, and reduce inflammatory responses in patients with KOA, exerting good safety.

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