The Clinical Study Of Jingshu Granule In Treating Cervical Spondylosis Of Nerve Root Type (blood Stasis Blocking Collaterals)

Objective:To evaluate the efficacy and safety of Jingshu Granules in the treatment of cervical spondylotic radiculopathy (blood-stasis obstruction syndrome).Methods:The block randomized, double-blind, double-dummy, Jingtong Granules parallel contrast and multi-center clinical trial was conducted by4Drug Clinical Research Bases.440subjects were enrolled and randomly divided into test group and control group. The Patients in test group were treated with Jinshu Granules (1bag per time, three times daily). The Patients in control group were treated with Jingtong Granules (1bag per time, three times daily). Course of treatment is4weeks. Clinical symptoms were recorded3times during the trial which was used to evaluate the efficacy and safety.Results:1.Curative effect evaluation:(1)Evaluation of TCM syndrome curative effect in Full Analysis Set (FAS):The total effective percentage was84.24%in test group and79.09%in control group; per-protocol set (PPS):The total effective percentage was84.08%in test group and79.25%in control group. Significant difference was found between2groups (P<0.05).(2)TCM symptom scores decreased in test group and control group after4weeks medication and difference with regard to baseline are statistically significant(P<0.01).(3)Clinical assessment scale for cervical spondylosis scores increased in test group and control group after4weeks medication and difference with regard to baseline are statistically significant(P<0.01).2.Safety analysis:Neither the relevant bad affairs(bad reaction) occured nor abnormality in safety check.Conclusion:1.Therapeutic efficacy of Jingshu Granules is better than Jingtong Granules therapeutic efficacy on the TCM syndromes.2.Increment rate of clinical assessment scale for cervical spondylosis in treat group (Jingshu Granules) is higher than control group (Jingtong Granules).3.Jingshu Granules is safe at therapeutic dosage.