A Phase 1/2 interventional study of Xingqi Daozhi Decoction and Placebo Group in Schizophrenia and Antipsychotic Drug, sponsored by Shanghai Mental Health Center. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Shanghai Mental Health Center · Phase 1/2, Interventional, and Treatment
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.
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.
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 46 is below the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Shanghai Mental Health Center is the lead sponsor of 272 studies on the registry; 91 are open to participants now.
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Meets the , Fifth Edition (DSM-5) diagnostic criteria for schizophrenia.
Positive and Negative Syndrome Scale (PANSS) total score ≤95, with a PANSS negative symptom subscale score ≤28.
Meets the Rome IV diagnostic criteria for functional constipation with a qi stagnation pattern.
Aged 18 to 65 years. Has at least a junior high school education and is able to complete self-report questionnaires.
Has not used other medications known to cause constipation within the past 3 months.
Has had no history of constipation within the past 2 years and no previous gastrointestinal disease.
Developed constipation after initiation of antipsychotic medication.
Exclusion Criteria:
Meets diagnostic criteria for any psychiatric disorder other than schizophrenia.
Is unable to maintain a normal diet because of psychiatric symptoms, or requires a special diet such as a diabetic diet, soft diet, liquid diet, fasting, or restriction of oral intake due to individual clinical circumstances.
Uses other medications that may cause or aggravate constipation. Has had constipation within the past 2 years or has a history of gastrointestinal disease.
Has lactose intolerance. Has medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.
Is pregnant, planning pregnancy in the near future, or breastfeeding.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Xingqi Daozhi Decoction Group
Drug: Xingqi Daozhi Decoction
Placebo Group
Drug: Placebo Group
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
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.
Overall CSBM Responder Rate
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2027, 6 months later.
Of 18 phase 1/2 interventional studies under Schizophrenia, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 70. This study's planned 6 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 10, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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