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Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation

NCT07767526 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-17

No results posted yet for this 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.

Conditions

Interventions

DRUG

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

DRUG

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.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-06-01
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07767526 on ClinicalTrials.gov