Constipation of Parkinson'
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Parkinson's disease patients who satisfy all of the following conditions: 1) Adult male or female patients age 20 or older 2) Patients presenting with symptoms of constipation despite treatment with Western medicine laxatives 3) Patients with <=3 defecation/week, which has lasted for 6 months or longer 4) Patients who complain of one or more of the following symptoms which has lasted for 6 months or longer ?Lumpy or hard stools in >=1 out of 4 defecation ?Sensation of incomplete evacuation in >=1 out of 4 defecations ?Straining in >=1 out of 4 defecations 5) Patients willing and able to answer the self-administered questionnaire 6) Written informed consent from patients who are able to read and understand the consent document
Exclusion criteria
Exclusion criteria: 1) Pregnant women or nursing mothers 2) Patients with apparent obstructions (such as tumors or hernias) in the intestinal tract 3) Patients with drug-induced constipation 4) Patients with known megacolon/megarectum or intestinal pseudo-obstruction 5) Patients who have undergone prior gastrointestinal surgery or abdominal surgery during the 3 months prior to the start of the study 6) Patients with significant cardiac, hepatic, pulmonary, renal, or mental diseases 7) Patients with severe clinical findings or abnormal laboratory (hematology/urinalysis) findings 8) Patients with uncontrolled hypertension, hyperaldosteronism, hypokalemia, or myopathy 9) Patients who may not comply with this research study protocol 10) Patients diagnosed with cancer within 5 years from the start of the study (except for carcinoma in situ) 11) Patients with constipation that is controlled through treatment with Mashiningan or Daiokanzoto prior to the start of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constipation assessment scale | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Bristol stool scale 2) Presence or absence of adverse effects 3) Other individual outcomes, obtained from responses to the questionnaire(Abdominal bloating, stool frequency, sensation of incomplete evacuation, straining, etc.) | — |
Countries
Japan
Contacts
Jichi Medical University Oriental Medicine