Functional consitipation
Conditions
Interventions
Experimental group:Drug intervention (6 capsules 2 times/day for 2 weeks prior to dosing 3 capsules 2 times/day for weeks 3 to 12)
Control group:Drug intervention (3 capsules of Qihuangtongmi soft capsule + 3 capsules of Qihuangtongmi soft capsule simulant twice a day 2 weeks before medication
3 capsules twice a day 3 weeks to 12 weeks)
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Functional constipation diagnosed clinically and meeting the Rome ? diagnostic criteria; 2. The age = is 60 years old and the gender is not limited; 3. Voluntary participation and signing of informed consent.
Exclusion criteria
Exclusion criteria: 1. In the past 12 months colonoscopy or barium enema examination has found intestinal stenosis caused by organic intestinal lesions (such as tumor inflammation anal fissure Crohn's disease intestinal adhesion intestinal tuberculosis etc.) or other systemic diseases involving the digestive tract [nervous system diseases (such as: Constipation caused by Parkinson's disease spinal cord injury multiple sclerosis etc.) muscle diseases (such as amyloidosis dermatomyositis etc.) and mental disorders (such as depression etc.); 2. Constipation caused by drug factors (such as the use of opioids anticholinergics calcium antagonists anti-tremor drugs antipsychotics antihistamines spasmolytics diuretics monoamine oxidase inhibitors sympathetics antacids containing aluminum or calcium iron agents antidiarrheal drugs non-steroidal anti-inflammatory drugs etc.) or other secondary constipation with clear etiology; 3. There is evidence of organic gastrointestinal abnormalities or diseases affecting gastrointestinal function including previous gastrointestinal surgery history or other diseases or conditions that researchers believe will significantly affect gastrointestinal function [such as irritable bowel syndrome (IBS) symptoms or bowel disorders caused by anal lesions etc.]; 4. Patients with serious primary diseases such as cardiovascular and cerebrovascular liver kidney endocrine nervous system and hematopoietic system (including unstable angina pectoris acute myocardial infarction within 6 months during the screening period severe arrhythmia cardiac function grade ?-? hypertension grade 3 or malignant hypertension); 5. ALT AST > upper normal value SCr > upper normal value TBIL> upper normal value; 6. Those who cannot comply due to alcohol drug abuse or mental factors; 7. Those who have used laxative drugs within the last 2 weeks (except for emergency treatment); 8. Patients who have participated in clinical trials of other drugs within the last month; 9. Allergic or allergic to the ingredients of this product and remedies; 10. Researchers do not consider candidates suitable for admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total response rate for complete spontaneous bowel movement times; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change value of bowel movement;Change in abdominal distension and abdominal pain scores;complete spontaneous bowel movement times;Use of Remedial Drugs;Fecal character score;Change value of spontaneous bowel movement;complete spontaneous bowel movement times;Constipation Severity Score Change;Quality of life score for patients with constipation;Onset time of first defecation;Total number of fully autonomous defecations;response rate for complete spontaneous bowel movement times;response rate for complete spontaneous bowel movement times;Recurrence rate of functional constipation;complete spontaneous bowel movement times;Fecal character score change valu; | — |
Countries
China
Contacts
Public ContactYinglian Xiao
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed