Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial

Schizophrenia Clinical Trial

Official title:

Nurse Practitioner

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05528146
• Other study ID #: Hungkuang University
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: September 2022
• Source: Hungkuang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: August 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. DSM-V was diagnoses with schizophrenia inpatients.

2. Aged between 20 years and above.

3. 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.

4. Clear awareness and able to communicate in Chinese and Taiwanese.

Exclusion Criteria:

1. 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.

2. 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.

3. Those who are unable to cooperate due to obvious mental symptoms.

4. History of grain allergy, asthma.

Related Conditions & MeSH terms

• Constipation
• Schizophrenia

Intervention

Dietary Supplement:
• Psyllium huks
psyllium in 250ml of water

Locations

Country	Name	City	State
Taiwan	Changhua Hospitol	Chang Hua	Puxin Township

Sponsors (1)

Lead Sponsor	Collaborator
Hungkuang University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Constipation Assessment Scale, CAS	improved constipation symptoms	4weeks
Primary	bowel movement	increased stool frequency	4weeks
Secondary	Stool type	improved stool type (bristol stool form)	4weeks