Functional constipation (qi and yin deficiency syndrome)
Conditions
Interventions
Treatment group 2:Phase 1 14±2 days: Shouhui Laxative Capsules
Phase 2 42±4 days: First Companion Probiotics.
Treatment group 1:The first stage is 14±2 days: Shouhui Laxative Capsule + Shouhui Mate Probiotic
Treatment group 3:Phase 1 14±2 days: Shouhui Laxative Capsules
Phase 2: None
Sponsors
Liaocheng Chiping District Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Age 18~70 years old (including boundary value), gender is not limited 2: Meets Western medical diagnostic criteria for functional constipation 3: The syndrome differentiation in traditional Chinese medicine is the deficiency pattern of qi and yin 4: Voluntarily participate in this trial and sign a written informed consent document
Exclusion criteria
Exclusion criteria: 1: Subjects have intestinal organic diseases and other diseases that can cause constipation, such as tumors, inflammatory bowel disease, megacolon, intestinal obstruction, anorectal lesions, parathyroid diseases, diabetes mellitus, etc 2: Constipation caused by taking medications, such as anesthetics, antidepressants, aluminum preparations, calcium channel antagonists, antihistamines, diuretics, etc 3: Within 14 days prior to enrollment, those who have used drugs that promote gastrointestinal dynamics, traditional Chinese medicine for the treatment of constipation and digestive tract microecological preparations (such as those containing probiotics and prebiotics). 4: ALT and AST are 1.5 times higher than the upper limit of normal, and the upper limit of SCR is 1.2 times 5: Suspected or proven history of alcohol or drug abuse 6: Those with allergies, known or suspected allergies to the test drugs and products and their components 7: Combined with serious cardiovascular, respiratory, renal, hematologic, endocrine, neurological and psychiatric and other systemic diseases, which in the opinion of the investigator will affect the trial evaluator 8: Women who are pregnant or preparing to become pregnant and breastfeeding 9: Those who have participated in other drug clinical trials within 3 months before enrollment 10: Other patients who are considered by the investigator to be unsuitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of complete spontaneous bowel movements (CSBM) response rate:Proportion of patients who meet; | — |
Secondary
| Measure | Time frame |
|---|---|
| The number of bowel movements (BM) in the last week of the treatment period compared to baseline;Constipation Quality of Life Assessment Scale (PAC-QOL);Stool Condition (Using the Bristol Stool Character Scale) score compared to baseline in the last wee;TCM Syndrome Points;Mean weekly stool trait score;Occurrence of completely spontaneous bowel movement (CSBM) within 24 hours of starting treatment;Changes in intestinal flora;Proportion of subjects with an average of 3 complete spontaneous bowel movements (CSBM=) per week wi;Remediation of drug use;The average number of SBMs per week;The number of spontaneous bowel movements (SBM) in the last week of the treatment period compared to; | — |
Countries
China
Contacts
Public ContactQingrong Jiang
Liaocheng Chiping District Traditional Chinese Medicine Hospital
Outcome results
None listed