Constipation after ischemic stroke Digestive System Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed with ischemic stroke according to the diagnostic criteria specified by the World Health Organization (WHO) 2. With symptoms of constipation according to the Rome III functional constipation criteria 3. 2 weeks to 6 months after stroke onset 4. Aged between 30 and 75 years old, either gender 5. The Glasgow Coma Scale (GCS) score = 7 and the National Institute of Health Stroke Scale (NIHSS) = 21, which indicates that participants are conscious and without dysfunctions in comprehension 6. With no previous medical history of constipation before stroke onset and the symptoms of constipation present at least 2 weeks continuously after stroke 7. No use of gastrointestinal drugs 1 week before randomisation (except for emergency drugs) 8. No acupuncture treatment for constipation in the previous 2 weeks 9. Volunteered to join the clinical trial and provided a signed informed consent form
Exclusion criteria
Exclusion criteria: 1. Irritable bowel syndrome (IBS) and constipation secondary to organic diseases (for example, endocrine, metabolic or postoperative diseases) or drugs 2. Participants with abdominal aneurysm, hepatosplenomegaly, serious cardiovascular, liver, kidney or psychiatric disease, or severe dystrophy who cannot cooperate to be examined or treated 3. Pregnant women or women in lactation 4. Blood coagulation disorders, or administration of anticoagulant agents such as warfarin and heparin (participants treated with antiplatelet treatment such as asprin or clopidogrel as secondary prevention of cerebral infarction are eligible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of mean weekly complete spontaneous bowel movements (CSBMs) from baseline; measured at the 4th and the 8th week after randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The change of mean weekly spontaneous bowel movements (SBMs) from baseline, measured at the 4th and the 8th week after randomisation 2. The change of mean scores of stool consistency from baseline, measured at the 4th and the 8th week after randomisation 3. The change of mean scores of straining during defecation from baseline, measured at the 4th and the 8th week after randomisation 4. The change of weekly frequency of using laxatives from baseline, measured at the 4th and the 8th week after randomisation | — |
Countries
China