A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern

Antipsychotic-induced constipation is a common and clinically important adverse effect in patients receiving antipsychotic treatment. Anticholinergic and other pharmacological effects of antipsychotic medications may reduce gastrointestinal motility and intestinal secretion, leading to difficulty with defecation, abdominal distension, and other gastrointestinal symptoms. In severe cases, constipation may progress to serious gastrointestinal complications and may also negatively affect quality of life and adherence to psychiatric treatment.

From the perspective of traditional Chinese medicine, constipation with a qi stagnation pattern is characterized by difficult defecation accompanied by symptoms such as abdominal distension, belching, frequent passage of gas, and a sensation of incomplete evacuation. Treatment is directed toward regulating qi, relieving stagnation, and promoting bowel movements. Previous clinical observations of Xingqi Daozhi Decoction in constipation with a qi stagnation pattern suggested potential therapeutic benefit and acceptable tolerability, providing the rationale for further evaluation in patients with antipsychotic-induced constipation.

This exploratory study is designed to evaluate whether Xingqi Daozhi Decoction can improve constipation associated with antipsychotic treatment while maintaining acceptable safety and tolerability. Participants will undergo standardized clinical assessments throughout the treatment period, including evaluation of bowel habits, constipation-related symptoms, quality of life, psychiatric symptoms, treatment-emergent adverse effects, and routine safety parameters. Rescue treatment with glycerin enema may be used under predefined conditions when participants have no bowel movement for more than 3 consecutive days accompanied by abdominal discomfort, and its use will be recorded in the study documentation.

In addition to clinical efficacy and safety assessments, stool samples will be collected at selected time points for exploratory analyses of gut microbial composition and metabolites, including 16S rRNA sequencing and short-chain fatty acid measurements. These exploratory analyses are intended to investigate possible biological changes associated with treatment and to provide preliminary evidence regarding potential mechanisms of action.

After completion of the 8-week treatment period, participants may voluntarily enter an extended follow-up period of up to 1 year for continued clinical symptom assessment and telephone consultation.