Functional constipation
Conditions
Interventions
test group:Runner's Bowel Ning Shen Cream taken orally for four weeks
control group:Runchang Ningshen Cream Placebo Oral for 4 Weeks
Sponsors
Shuguang Hospital, Shanghai University of Traditional Chinese Medicine,
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. age 18-65 years old (including borderline values) and gender; 2. patients who meet the diagnostic criteria of functional constipation of Rome IV; 3. Patients who meet the TCM diagnostic criteria of Yin deficiency or Blood deficiency; 4. Possess colonoscopy results with colonoscopy diagnosis of no obvious abnormality or diagnosis of colon polyps (size not exceeding 0.5cm and number not exceeding 3), based on colonoscopy results from a tertiary-level hospital within 12 months prior to screening; 5. The average number of voluntary defecation is less than 3 times per week during the introductory period; 6. agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. those with constipation caused by intestinal stenosis due to organic lesions of the intestinal tract (e.g., obstructive diseases, digestive tract tumours, inflammatory bowel disease, intestinal tuberculosis, etc.) diagnosed by the investigator or those with defecation disorders due to severe organic anal lesions; 2. those with a history of digestive tract tumour or other systemic diseases involving the digestive tract, as well as those with secondary constipation of clear etiology; 3. those with drug-associated constipation: regular use of drugs that clearly cause constipation in the drug insert 4 weeks prior to screening, such as antidepressants, antiepileptics, antihistamines, antitremor paralysers, antipsychotics, antispasmodics, calcium antagonists, diuretics, monoamine oxidase inhibitors, opiates, sympathomimetics, antacids containing aluminium or calcium, calcium, iron, antidiarrhoeals, non-steroidal anti-inflammatory drugs, etc. or those who could not stop using these drugs during the study. Those who cannot discontinue these medications during the study; 4. Endocrine and metabolic diseases (diabetes mellitus [diabetes mellitus with a duration of less than 10 years and screening glycated haemoglobin 1.5 times the upper limit of normal value and Scr > upper limit of normal value; 7. those with allergy or hypersensitivity (e.g., allergy to two or more drugs or foods) to the test drug, the remedial drug, or the components of the drug; 8. patients with a history of psychiatric system disorders, such as major depression and major anxiety disorders 9. psychological, mental status or cognitive ability, language expression ability, etc. assessed by the investigator can not cooperate with the completion of the clinical trial; 10. suspected or confirmed history of alcohol or drug abuse; 11. suspected or confirmed eating disorders such as anorexia or bulimia; 12. those who have participated in a clinical trial of another drug within 3 months prior to screening; 13. other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Completely voluntary bowel movement (CSBM) response rate;Time taken for 1st spontaneous bowel movement (SBM) to occur after initial dose;Value of change from baseline in the number of SBMs in the final week;Mean weekly faecal character score during the treatment period;Value of change from baseline in faecal trait (using the Bristol Faecal Trait Scale) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Value of change from baseline in patients' constipation major symptom scores on day 28 of dosing;;Change from baseline in TCM symptom scores for constipation in patients on day 28 of drug administration;Value of change from baseline in patients' constipation quality of life assessment scale (PAC-QOL) scores on day 28 of medication administration; | — |
Countries
china
Contacts
Public Contactjianghong ling
Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed