Abstract
Background: Neck pain, sensory disturbance and motor dysfunction in most patients suffered cervical spondylotic myelopathy. However, some conservative treatments are limited by their modest effectiveness. In the other hand, surgical treatment is necessary when symptoms are refractory to conservative treatments and neurological function of the patients has deteriorated. Many patients use complementary and alternative medicine, including traditional Chinese medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Yiqi-Huayu-Tongsui granule, a compound traditional Chinese herbal medicine, on symptoms in patients with mild or moderate cervical spondylotic myelopathy.Methods/Design: A randomized, double blinded, placebo-controlled clinical trial to evaluate the efficacy and safety of Yiqi-Huayu-Tongsui granule is proposed. 72 patients in Longhua Hospital with the diagnosis of mild or moderate cervical spondylotic myelopathy will be randomly allocated into two groups, and treated with Yiqi-Huayu-Tongsui granule or placebo. The prescription of the trial drugs (Yiqi-Huayu-Tongsui granule / placebo) is 20 grams twice a day for 3 months. The primary outcome measurements include VAS, JOA and NDI score. The secondary outcome measurements are electromyogram and Pfirrmann classification.Discussion: Yiqi-Huayu-Tongsui granule has been established and applied in Longhua Hospital for many years. As it has a potential benefit in treating mild or moderate cervical spondylotic myelopathy, we designed a double-blind, prospective, randomized controlled trial and would like to publish the results and conclusions later. If Yiqi-Huayu-Tongsui granule can alleviate neck pain, sensory disturbance, and even motor dysfunction without adverse effects, it may be a unique strategy for the treatment of mild or moderate cervical spondylotic myelopathy.Trial registration: Chinese Clinical Trial Registry ID: ChiCTR1900028192. Registered 15 December 2019, http://www.chictr.org.cn/edit.aspx?pid=46913&htm=4
Randomized, double-blind, parallel-controlled clinical trial on correspondence of prescriptions and Traditional Chinese Medicine syndrome of ischemic stroke