Objective To evaluate the design quality of randomized controlled clinical trial of Chinese Medicine treatment of cyclomastopathy. Methods All published research articles about randomized controlled clinical trial of Chinese Medicine treatment of cyclomastopathy from Chinese Journal Full-Text Database

Wan Fang Data

and Vip Database from January of 2009 to December of 2013 were reviewed. The clinical trial design was evaluated from the aspects of ethics design

methodology design

medicine design and management design. Results There were 248 published research articles in total. In 25 papers（ 10. 1%）

informed consent was considered to be signed by subjects when a study was designed. All 248 papers did not show whether the research scheme was approved by an ethics committee before it was carried out. Sixteen papers（ 6. 5%） described the random methods

among them only1 paper（ 0. 4%） mentioned that random allocation concealment by opaque envelopes was used. Six papers（ 2. 4%）reported to adopt single blind method

while 6 papers described to use double blind method. Neither specific research hypothesis nor basis of calculating sample size was found in the 248 papers. 130 papers（ 52. 4%） presented definite diagnostic criteria

and 40 papers（ 16. 1%） provided inclusive and exclusive criteria. Only 7 papers（ 2. 8%）contained contents of combined medication. All papers did not show calculating method of treatment compliance and statistical method of poor compliance cases. 246 papers（ 99. 2%） adopted composite effect index. 51 papers（ 20. 6%） reported safety evaluation results. One paper（ 0. 4%） illustrated the time for outcome measurements. 29papers（ 11. 7%） reported follow-ups. Management design was not considered in all the papers. Conclusion The design quality of randomized controlled clinical trials of Chinese Medicine of treatment of cyclomastopathy should be improved. Multidisciplinary cooperation should be strengthened.