Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation

Condition(s) studied

Investigational drug(s) / intervention(s)

Xingqi Daozhi Decoction: Participants assigned to this arm will receive Xingqi Daozhi Decoction granules twice daily for 8 weeks. One packet will be taken each time, approximately 30 minutes after breakfast and dinner. The formulation contains Cistanche deserticola 30 g, Magnolia officinalis 15 g, Raphanus sativus seed 15 g, and Areca catechu pericarp 10 g. Participants will be monitored for constipation symptoms, bowel movements, psychiatric symptoms, safety, and adverse events throughout the treatment period

Placebo Group: Participants assigned to this arm will receive Xingqi Daozhi Decoction placebo granules twice daily for 8 weeks. The placebo contains 1/10 of the active ingredients of Xingqi Daozhi Decoction, together with food-grade coloring, bittering agents, and lactose, and is matched to the active treatment in appearance, dosage, and administration. One packet will be taken approximately 30 minutes after breakfast and dinner.

Study summary

Antipsychotic medications are widely used to treat schizophrenia but may cause constipation, which can lead to abdominal discomfort, reduced quality of life, and poor treatment adherence. Xingqi Daozhi Decoction is a traditional Chinese medicine formula used to relieve constipation associated with qi stagnation. This study aims to evaluate the effectiveness and safety of Xingqi Daozhi Decoction for antipsychotic-induced constipation with a qi stagnation pattern.

This is a single-center, randomized, double-blind, placebo-controlled exploratory study. A total of 46 participants with schizophrenia who developed constipation after taking antipsychotic medications will be enrolled. Participants will be randomly assigned to receive either Xingqi Daozhi Decoction granules or matching placebo granules twice daily for 8 weeks. Neither the participants nor the treating clinicians and outcome assessors will know the treatment assignment during the study.

Participants will be evaluated regularly during treatment. The study will assess changes in bowel movements, constipation symptoms, constipation-related quality of life, and treatment safety. Participants will also undergo routine clinical and laboratory safety assessments, and adverse events will be recorded throughout the study. The primary outcome focuses on the proportion of participants who achieve an improvement in complete spontaneous bowel movements during treatment.

Eligibility

Primary outcome measure(s)

• Overall CSBM Responder Rate — 8 weeks
  A weekly CSBM responder is defined as a participant who has at least 3 complete spontaneous bowel movements (CSBMs) during a given week and an increase of at least 1 CSBM per week from baseline. An overall CSBM responder is defined as a participant who meets the weekly CSBM responder criteria for at least 50% of the weeks during the 8-week treatment period. A CSBM is defined as a spontaneous bowel movement occurring without the use of rescue laxatives or manual assistance and accompanied by a sensation of complete evacuation.

Trial sites (1)

More Shanghai Mental Health Center trials in China

Other trials for the same condition