functional constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age range from 18 to 65 years old, regardless of gender 2. Meets the diagnostic criteria for functional constipation 3. Colonoscopy excludes organic diseases 4.Subjects voluntarily sign a written informed consent form
Exclusion criteria
Exclusion criteria: 1. Individuals with a known history of allergies to drugs containing similar components and chemical structures to kiwifruit or control drugs 2.Have serious heart, lung, liver, kidney, nerve, endocrine and other system diseases, including diabetes, diffuse dyskinesia, connective tissue disease, Multiple sclerosis, Parkinson's disease, spinal cord injury or cerebrovascular accident 3.Severe abdominal pain, with a visual analog score of over 7 points for pain 4. Anal fissure, pelvic floor dysfunction, Rectal prolapse and other anorectal diseases affecting defecation 5. Those with warning symptoms of intestinal tumor, including gastrointestinal bleeding, Iron-deficiency anemia of unknown cause or Weight loss 6.Patients with Inflammatory bowel disease 7.Individuals with a history of gastrointestinal surgery (excluding those who have undergone appendectomy or cholecystectomy for more than 6 months) 8. Participated in clinical research on other investigational drugs within one month 9. Individuals who are addicted to alcohol, drugs, or known to have drug dependence 10. Patients with psychological disorders 11.Pregnant, expectant or lactating women and staff directly involved in this study 12.Other situations where the researcher determines that it is not suitable to participate in clinical research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of complete spontaneous bowel movements per week;Abundance and diversity of Gut microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of spontaneous bowel movements per week;Evaluation of fecal characteristics;gastrointestinal symptom rating scale;Abdominal pain, bloating, abdominal discomfort, incomplete defecation, difficulty in defecation;Number of times rescue drugs are used during treatment;Treatment satisfaction score;patient assessment of constipation quality of life questionnaire;Patient Assessment of Constipation Symptoms ;Knowles Eccersley Scott Symptom;SF-36; | — |
Countries
China
Contacts
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine