Abstract: Objective This study aimed to evaluate the short-term clinical efficacy of topical application of anti-inflammatory and analgesic herbal medicine in the treatment of middle-aged and elderly patients with knee osteoarthritis（KOA）. Methods A total of 60 KOA patients admitted to Huai’an Hospital of Traditional Chinese Medicine were randomly divided into a control group（n = 30） and a study group（n = 30） according to the random number table method. The control group received celecoxib capsules, while the study group received additional topical anti-inflammatory and analgesic herbal medicine. Therapeutic outcomes were compared between the two groups. Results After 8 weeks of treatment, the study group showed a significantly higher total clinical effective rate than the control group（P ＜ 0.05）. At both 4 and 8 weeks post-treatment, the study group demonstrated superior improvements in traditional Chinese medicine syndrome scores,Western Ontario and McMaster Universities Osteoarthritis Index（WOMAC） scores, visual analog scale（VAS） scores, inflammatory factor levels, cartilage repair biomarkers, knee flexion range of motion, patellar superior pole circumference, and gait parameters compared to the control group（P ＜ 0.05）. Conclusion The application of topical anti-inflammatory and analgesic herbal medicine enhances the total clinical effective rate and cartilage repair factor levels in KOA patients, alleviates clinical symptoms, improves knee joint function and gait,reduces pain, and decreases inflammatory markers.