Abstract: In treatment of patients with chronic func-tional constipation, the clinical trials of TCM new drugs should include cases in accordance with the principle of shunting diagnosis and treatment. If the cases do not ob-tain effect, they are converted to secondary diagnosis and treatment, and the results will be feedback to re-evaluate the curative effect of the new drug. The design of protocol will take into account the drug formulae and the charac-teristics of the effects.This design may guarantee the ac-curacy of the results of trials and safety of subject.

Key words: TCM new drug, protocol, chronic idio-pathic constipation, clinical trial