Efficacy and safety of Xinglouchengqi decoction for acute ischemic stroke with constipation： study protocol for a randomized con-trolled trial

OBJECTIVE： To investigate the efficacy and safetyof Xinglouchengqi （XLCQ） decoction in treatmentof acute ischemic stroke with constipation.METHODS： In this prospective, multicenter, asses-sor-blinded, randomized controlled trial, 360 eligi-ble participants will be randomized to the XLCQgroup or the control group. Participants in the XL-CQ group will receive XLCQ decoction, while thosein the control group will undergo clysis therapy us-ing glycerin enemas or oral administration of lactu-lose solution. Both groups will undergo a treat-ment period of （5 ＋ 2） d and a 1-month follow-up.The primary outcome measure will be the Constipa-tion Scale score. The secondary outcome measureswill include scores on the National Institutes ofHealth Stroke Scale, the Traditional Chinese Medi-cine （TCM） Stroke Scale, the Diagnostic Scale forTCM Syndromes of Ischemic Stroke and TCM Scalefor Syndrome of Phlegm-heat and Fu-organ Excess.Therapeutic mechanism outcomes and safety out-comes will also be assessed. Assessments will beconducted at baseline, at the end of the treatmentperiod, and at the follow-up. Moreover, daily visitswill be scheduled to grade the status of constipa-tion during the treatment period.