Ancient herbal blend put to the test against Drug-Induced constipation
NCT ID NCT07767526
First seen Aug 17, 2026 · Last updated Aug 18, 2026 · Updated 1 time
Summary
This trial investigates whether a traditional Chinese medicine formula, Xingqi Daozhi Decoction, can relieve constipation that often occurs as a side effect of antipsychotic medications in people with schizophrenia. The study will enroll 46 adults with schizophrenia who have developed constipation, and randomly assign them to receive either the herbal granules or a placebo twice daily for 8 weeks. Neither participants nor researchers will know who gets which treatment. The main goal is to see if the herbal formula improves the frequency and completeness of spontaneous bowel movements, while also monitoring safety and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Xingqi Daozhi Decoction, a traditional Chinese herbal formula
- What this could lead to
- If effective, this herbal remedy could offer a new, well-tolerated option to relieve constipation in people taking antipsychotic medications, potentially improving comfort and treatment adherence.
- What could go wrong
- This is an early-stage exploratory trial with a small number of participants, so results may not be conclusive or widely applicable. Herbal remedies can also have side effects or interact with other medications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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. Exclusion Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shanghai Mental Health Center
Shanghai, China
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Other studies related to the condition(s) this trial covers.
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