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

Primary Purpose

Schizophrenia, Psyllium, Constipation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Psyllium huks
Sponsored by
Hungkuang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Changhua Hospitol

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A

B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

bowel movement
increased stool frequency

Secondary Outcome Measures

Stool type
improved stool type (bristol stool form)

Full Information

First Posted
September 1, 2022
Last Updated
September 1, 2022
Sponsor
Hungkuang University
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1. Study Identification

Unique Protocol Identification Number
NCT05528146
Brief Title
Effects of Psyllium on Constipation in Schizo-phrenic: A Randomized Controlled Crossover Trial
Official Title
Nurse Practitioner
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hungkuang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psyllium, Constipation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Psyllium huks
Intervention Description
psyllium in 250ml of water
Primary Outcome Measure Information:
Title
bowel movement
Description
increased stool frequency
Time Frame
4weeks
Secondary Outcome Measure Information:
Title
Stool type
Description
improved stool type (bristol stool form)
Time Frame
4weeks
Other Pre-specified Outcome Measures:
Title
Constipation Assessment Scale, CAS
Description
improved constipation symptoms
Time Frame
4weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Changhua Hospitol
City
Chang Hua
State/Province
Puxin Township
ZIP/Postal Code
513011
Country
Taiwan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chin-Hsiu Wang
Phone
886-048298686
Ext
5006
Email
232936showshow@gmail.com
First Name & Middle Initial & Last Name & Degree
Mei-Ling Lin
Phone
886-0426315682
Ext
7083
Email
linml@sunrise.hk.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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