ObjectiveTo evaluate the efficacy and safety of Fugui ostealgia particles for cervical spondylosis (Yang-asthenia and cold-damp type). MethodsFrom December 2010 to July 2011, we carried out a multi-centered, randomized, double-blind and double-simulation clinical observation study based on the Guiding Principles for the Clinical Research on New Chinese Traditional Medicine (TCM). A total of 240 patients were divided into experimental group and control group with the number of patients at a ratio of 3:1. The treatment group (n=180) was treated by Fugui ostealgia particles, while patients in the control group (n=60) received Kangguzengsheng capsules. The treatment course lasted for 90 days. ResultsThe total effective rate in the experimental group was 92.44%, and was 75.47% in the control group, with a significant difference between the two groups (P<0.05). The total effective rate for TCM syndromes was significantly different between the two groups (P<0.05). The effect on main symptoms such as nuchal pain, aversion to cold, and cold hands and feet, was significantly different between the two groups (P<0.05). Laboratory test results showed no abnormality before and after treatment, and no drug-related adverse reactions occurred. ConclusionFugui ostealgia particles are safe and effective for the treatment of Yang-asthenia and cold-damp type cervical spondylosis, especially for the treatment of nuchal pain, aversion to cold, and cold hands and feet.