A randomized, open-label, parallel-controlled clinical study on the efficacy and safety of Shouhuitongbian Capsule combined with Shouhuitongbian Probiotics in the treatment of functional constipation (qi and yin deficiency syndrome)
- Conditions
- Functional constipation (qi and yin deficiency syndrome)
- Registration Number
- ITMCTR2024000007
- Lead Sponsor
- iaocheng Chiping District Traditional Chinese Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of complete spontaneous bowel movements (CSBM) response rate:Proportion of patients who meet;
- Secondary Outcome Measures
Name Time Method 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;