SchizophreniaNCT05528146
Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial
A study testing Psyllium huks in people with Schizophrenia and Constipation, run by Hungkuang University at 1 site in Taiwan.
Trial summary
Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia, Constipation
- What is being tested?
- Psyllium huks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 7 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-V was diagnoses with schizophrenia inpatients.
- Aged between 20 years and above.
- Those who defecate less than 3 times a week, or those who have Bristol stool form scale between 1 and 2, or those who have constipation assessment scale (CAS) scores more than one point from questions 3 to 8; Or use PRN stool softeners (including oral and suppository) at least once a week.
- Clear awareness and able to communicate in Chinese and Taiwanese.
Who cannot join
- Patients with intestinal diseases such as colon cancer, irritable bowel syndrome and other organic intestinal diseases such as rectal bleeding, intestinal surgery, rectal prolapse and other medical history.
- Cases with positive fecal occult blood test in the past six months, changes in stool thickness for one month, history of iron deficiency anemia, and unexplained weight loss for one month.
- Those who are unable to cooperate due to obvious mental symptoms.
- History of grain allergy, asthma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Psyllium on Constipation in Schizophrenic: A Randomized Controlled Crossover Trial
Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.
Read the detailed description
The study was conducted in the psychiatric department of a hospital in the central region and utilized a crossover design involving a total of 42 patients with schizophrenia. The study employed a single-blind and simple randomization approach, with hospital wards divided into two groups. During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake. The research findings showed significant improvements in the frequency of constipation, stool consistency, and subjective experience of bowel movements in patients with schizophrenia following the intervention with psyllium husk.
- Conditions
- Schizophrenia, Constipation
- Being tested
- Psyllium huks
- Keywords
- Schizophrenia, Psyllium, Constipation
- Medical subject headings
- Schizophrenia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psyllium huksDietary supplement
psyllium in 250ml of water
| Study group | Role | What they receive |
|---|---|---|
| A group for women | Experimental | In a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect. Receives: Dietary Supplement: Psyllium huks |
| B group for man | Experimental | In a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect. Receives: Dietary Supplement: Psyllium huks |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of constipation
To assess the outcome measure of constipation frequency, researchers will collect the number of weekly bowel movements from participants by daily inquiries. Constipation, in this context, is defined as having fewer than three bowel movements per week. Additionally, researchers will record any associated discomfort or symptoms related to constipation.
Wilcoxon Signed Rank Test analysis showed a significant difference between the pre-test and the second stage (3.5 g/day psyllium) (z = -2.08, p = .04), Cohen's d = .39; the pre-test and the three stage (7 g/day psyllium), there was a statistically significant difference (z = -2.2, p = .03) , Cohen's d = .42
Measured: 4weeks
Secondary outcomes (1)
Stool type(bristol stool form)
To assess the outcome measure of stool consistency, researchers will utilize the Bristol Stool Scale, which categorizes stool types into seven categories. These categories will be further classified into three groups: constipation, normal, and diarrhea. Constipation, in this context, is defined as the presence of stool types falling within the constipation category, as specified on the Bristol Stool Scale. Researchers will collect this data through daily inquiries with participants and record any associated discomfort or symptoms related to constipation.
The Wilcoxon Signed Rank Test counted the stool patterns of the subjects and found that when taking 3.5g/day psyllium husk, the constipation pattern was reduced (z = -3.08, p = .002, Cohen's d= .54) , the amount of effect was reached; and the normal stool pattern increased (z = -4.35, p = < .001, Cohen's d = - .89).
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start1 Mar 2023
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hungkuang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Chin Hsiu, Hungkuang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528146
- Sponsor's protocol ID
- Hungkuang University
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Psyllium on Constipation in Schizophrenic: A Randomized Controlled Crossover Trial
- ClinicalTrials.gov ID
- NCT05528146
- Acronym / sponsor ID
- Hungkuang University
- Conditions
- Schizophrenia, Constipation
- Keywords
- Schizophrenia, Psyllium, Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hungkuang UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 6 Sep 2022 (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.
Constipation in schizophrenia is an important issue in clinical care. Constipation needs psychiatric professionals concerning and providing intervention because it may cause ileus and lead to death. The cause of constipation in patients may be due to side effects of antipsychotic medication, sedentary lifestyle, insufficient water intake, fiber, etc. The study aims to increase fiber of the consumption of psyllium to assess the constipation effectiveness in schizophrenics. The study conducted a crossover research design. G-power was used to calculate the 22 subjects in each of the two groups. A total of 44 patients with constipation who were schizophrenics will participate in the study. Patients will use simple randomly to be divided into two groups based on their live ward for pre-testing. These two groups will receive either psyllium 3.5 g/day or 7 g/day for 4 weeks in a single-blind, crossover trial. The trial will stop 1week after the first phase and post-test. Then, two groups will exchange the dose for 4 weeks. Post-test will record after finishing this second phase trial. This study can understand the benefits of psyllium on schizophrenics with constipation symptoms and can give professional suggestions to patients with constipation in the future.
Detailed description
The study was conducted in the psychiatric department of a hospital in the central region and utilized a crossover design involving a total of 42 patients with schizophrenia. The study employed a single-blind and simple randomization approach, with hospital wards divided into two groups. During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake. The research findings showed significant improvements in the frequency of constipation, stool consistency, and subjective experience of bowel movements in patients with schizophrenia following the intervention with psyllium husk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- During the first stage, both groups underwent pre-tests before the intervention. In the second stage, the two groups separately received a daily intake of 3.5 grams and 7 grams of psyllium husk for four weeks, followed by the first post-test. There was then a one-week washout period. In the third stage, the two groups switched the intake dosage of psyllium husk and underwent the second post-test after another four weeks of continuous intake.
| Arm | Type | Receives |
|---|---|---|
| A group for women | Experimental | Dietary Supplement: Psyllium huksIn a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect. |
| B group for man | Experimental | Dietary Supplement: Psyllium huksIn a single-blind crossover trial (male or female), these groups will receive 3.5 g/day or 7 g/day of psyllium for 4 weeks. The trial will stop 1 week after the first phase and post-test. The two groups will then swap doses for 4 weeks. Post-tests will be recorded upon completion of this Phase 2 trial. After completing the trial, determine the dose effect. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-V was diagnoses with schizophrenia inpatients.
- Aged between 20 years and above.
- Those who defecate less than 3 times a week, or those who have Bristol stool form scale between 1 and 2, or those who have constipation assessment scale (CAS) scores more than one point from questions 3 to 8; Or use PRN stool softeners (including oral and suppository) at least once a week.
- Clear awareness and able to communicate in Chinese and Taiwanese.
Key exclusion criteria (4 listed)
- Patients with intestinal diseases such as colon cancer, irritable bowel syndrome and other organic intestinal diseases such as rectal bleeding, intestinal surgery, rectal prolapse and other medical history.
- Cases with positive fecal occult blood test in the past six months, changes in stool thickness for one month, history of iron deficiency anemia, and unexplained weight loss for one month.
- Those who are unable to cooperate due to obvious mental symptoms.
- History of grain allergy, asthma.
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 |
|---|---|---|
| Psyllium hukspsyllium in 250ml of water | Dietary supplement | A group for women, B group for man |
Primary outcome
frequency of constipation
Time frame: 4weeks
To assess the outcome measure of constipation frequency, researchers will collect the number of weekly bowel movements from participants by daily inquiries. Constipation, in this context, is defined as having fewer than three bowel movements per week. Additionally, researchers will record any associated discomfort or symptoms related to constipation. Wilcoxon Signed Rank Test analysis showed a significant difference between the pre-test and the second stage (3.5 g/day psyllium) (z = -2.08, p = .04), Cohen's d = .39; the pre-test and the three stage (7 g/day psyllium), there was a statistically significant difference (z = -2.2, p = .03) , Cohen's d = .42
1 secondary outcome
Stool type(bristol stool form)
Time frame: 4weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psyllium huks in people with Schizophrenia and Constipation, run by Hungkuang University at 1 site in Taiwan.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 7 May 2025. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of constipation (time frame: 4weeks). 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 7 May 2025; AzTrials last refreshed its copy on 3 Nov 2026.