SchizophreniaPhase 1/2XQD-AICNCT07767526
Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation
A Phase 1/2 study testing Xingqi Daozhi Decoction in people with Schizophrenia and Antipsychotic Drug, run by Shanghai Mental Health Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Antipsychotic Drug
- What is being tested?
- Xingqi Daozhi Decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 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.
Who cannot join
- Meets DSM-5 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 clinically significant medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.
- Is pregnant, planning pregnancy in the near future, or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern
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.
Read the detailed description
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.
- Conditions
- Schizophrenia, Antipsychotic Drug
- Being tested
- Xingqi Daozhi Decoction, Placebo Group
- Keywords
- Schizophrenia, Xingqi Daozhi Decoction, Constipation, Antipsychotic drug, Traditional Chinese Medicine
- Medical subject headings
- Schizophrenia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xingqi Daozhi DecoctionDrug
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 GroupDrug
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 group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Xingqi Daozhi Decoction Group Receives: Drug: Xingqi Daozhi Decoction |
| Control Group | Placebo comparator | Placebo Group Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767526
- Sponsor's protocol ID
- 2026-38
- Other IDs
- 2022CX004
- Acronym
- XQD-AIC
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Exploratory Trial of Xingqi Daozhi Decoction for Antipsychotic-Induced Constipation With Qi Stagnation Pattern
- ClinicalTrials.gov ID
- NCT07767526
- Acronym / sponsor ID
- XQD-AIC / 2026-38
- Conditions
- Schizophrenia, Antipsychotic Drug
- Keywords
- Schizophrenia, Xingqi Daozhi Decoction, Constipation, Antipsychotic drug, Traditional Chinese Medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Xingqi Daozhi DecoctionXingqi Daozhi Decoction Group |
| Control Group | Placebo comparator | Drug: Placebo GroupPlacebo Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meets the Diagnostic and Statistical Manual of Mental Disorders, 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.
Key exclusion criteria (5 listed)
- Meets DSM-5 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 clinically significant medical conditions, including diabetes mellitus, hypothyroidism, connective tissue disease, or other significant physical illnesses.
- Is pregnant, planning pregnancy in the near future, or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xingqi Daozhi DecoctionParticipants 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 | Intervention Group |
| Placebo GroupParticipants 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. | Drug | Control Group |
Primary outcome
Overall CSBM Responder Rate
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Xingqi Daozhi Decoction in people with Schizophrenia and Antipsychotic Drug, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lanying L (13516816012, balindaliu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall CSBM Responder Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.