Efficacy and safety of Xinglouchengqi decoction for acute ischemic stroke with constipation: study protocol for a randomized controlled trial.

OBJECTIVE

To investigate the efficacy and safety of Xinglouchengqi (XLCQ) decoction in treatment of acute ischemic stroke with constipation.

METHODS

In this prospective, multicenter, assessor-blinded, randomized controlled trial, 360 eligible participants will be randomized to the XLCQ group or the control group. Participants in the XLCQ group will receive XLCQ decoction, while those in the control group will undergo clysis therapy using glycerin enemas or oral administration of lactulose solution. Both groups will undergo a treatment period of (5 ± 2) d and a 1-month follow-up. The primary outcome measure will be the Constipation Scale score. The secondary outcome measures will include scores on the National Institutes of Health Stroke Scale, the Traditional Chinese Medicine (TCM) Stroke Scale, the Diagnostic Scale for TCM Syndromes of Ischemic Stroke and TCM Scale for Syndrome of Phlegm-heat and Fu-organ Excess. Therapeutic mechanism outcomes and safety outcomes will also be assessed. Assessments will be conducted at baseline, at the end of the treatment period, and at the follow-up. Moreover, daily visits will be scheduled to grade the status of constipation during the treatment period.

DISCUSSION

The results of this study will provide scientific and objective data with which to assess the efficacy and safety of XLCQ decoction for patients with acute ischemic stroke and constipation.