Constipation
Conditions
Interventions
control group:placebo
test group:Jichuan decoction granules
Sponsors
Tianjin Xiqing Hospital
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Comply with the Western medical diagnostic criteria for functional constipation (Rome IV diagnostic criteria); 2) Comply with the diagnostic criteria of Yang deficiency of the spleen and kidney in Chinese medicine; 3) Be between the ages of 60-85 years old both male and female; 4) Be able to discontinue the use of medications that affect gastrointestinal motility during the Screening Period including: cholinesterase inhibitors; antispasmodics; laxatives; medications for constipation; tricyclic antidepressants; and other therapeutic medications that in the judgement of the investigator can alleviate or treat constipation and the symptoms associated with constipation; 5) Being on dietary fibre or medication for a concomitant condition such as hypertension must be in a stable dose for at least 30 days and maintained until the end of the treatment period; 6) Be willing to maintain a stable diet and lifestyle and be willing and able to complete the scale assessment; 7) Voluntarily participate and sign a written informed consent form and actively cooperate in the completion of the study.
Exclusion criteria
Exclusion criteria: 1) Constipation caused by narrowing of the intestinal tract due to combined organic diseases of the intestinal tract such as organic lesions of the rectum and colon (e.g. obstructive diseases digestive tumours inflammatory bowel diseases intestinal tuberculosis etc.) and anal lesions that cause pain in defecation and prevent defecation; 2) Inflammatory bowel disease digestive tract tumour or other systemic diseases involving the digestive tract such as neuromuscular lesions etc. as well as secondary constipation with a clear etiology; 3) Those with drug-related constipation: regular use of drugs that clearly cause constipation in the drug insert 4 weeks prior to screening such as antidepressants antiepileptics antihistamines antitremor paralytics antipsychotics antispasmodics calcium antagonists diuretics monoamine oxidase inhibitors opiates sympathomimetics antacids containing aluminium or calcium calcitonium iron anti-diarrhoeal drugs and non-steroidal anti-inflammatory drugs or those who cannot discontinue these drugs during the studyThose who cannot discontinue these drugs during the study; 4) Suffering from the following endocrine and metabolic diseases (diabetes mellitus [those with a disease duration of less than 10 years and a screening glycated haemoglobin of 1.5 times the upper limit of normal and Scr > upper limit of normal; 9)those who have 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; 10)those with a history of psychiatric systemic conditions such as major depression and major anxiety disorders; 11)Those with psychological or mental condition or cognitive ability language expression ability etc. who cannot cooperate to complete the clinical trial as assessed by the investigator; 12)Those with suspected or confirmed history of alcohol or drug abuse; 13)suspected or confirmed eating disorders such as anorexia and bulimia; 14)Those who have participated in clinical trials of other drugs within 3 months prior to screening; 15) other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean number of complete spontaneous bowel movements (CSBM) per week during the treatment period, and value of change from baseline;Response rate of complete spontaneous bowel movements (CSBM) in patients after 28 days of dosing;Mean number of spontaneous bowel movements (SBM) per week during the treatment period, and value of change from baseline;Time to 1st spontaneous bowel movement (SBM) after first dose of medication in the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean weekly patient Constipation Symptom Assessment Scale scores during the treatment period, and change from baseline values;Mean weekly faecal trait score (using the Bristol Faecal Trait Scale) during the treatment period, and change from baseline values;Use of remedial drugs during treatment;Mean weekly patient TCM Symptom Score Scale scores during the treatment period, and values of change from baseline;Recurrence of functional constipation during the follow-up period after the end of treatment (Bristol Faecal Characteristics Scale, PAC-QOL Scale, PAC-SYM score at 4 weeks after stopping the drug);Mean weekly faecal trait score (using the Wexner score) during the treatment period, and change from baseline values;Mean weekly Patient Assessment of Constipation Quality of Life Scale (PAC-QOL) scores during the treatment period, and change from baseline values;Mean weekly patient symptom self-assessment scale (PAC-SYM) scores during the treatment period, and comparison with baseline;Change in the number of fully voluntary bowel movements per week in patients during the follow-up period after the end of treatment (relative to the pre-intervention indicator);The total effective rate of treatment for patients after 28 days of medication; | — |
Countries
China
Contacts
Public ContactLihai
Tianjin Xiqing Hospital
Outcome results
None listed