NCT05528146

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

Effects of Psyllium on Constipation in Schizophrenic: A Randomized Controlled Crossover Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Hungkuang University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Psyllium huks	psyllium in 250ml of water

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-07-07
• Completion: 2023-07-07
• First posted: 2022-09-06
• Last updated: 2025-05-07

Locations

1 site across 1 country: Taiwan