Functional constipation
Conditions
Interventions
Experimental group:Heweitongxie granules, orally, 3 times daily
Control group:Placebo granules, orally, 3 times daily
Sponsors
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Meet the Western medical diagnostic criteria for functional constipation (Rome IV diagnostic criteria), and must meet the following two; a. Spontaneous defecation <3 times per week; b. Symptoms have been present for at least 6 months before diagnosis, and symptoms have been met within the last 3 months. 2) Meet the diagnostic criteria of spleen and stomach weakness and fu-qi obstruction in TCM; 3) Age 40-85 years old; 4) The ability to discontinue the use of drugs that affect gastrointestinal motility during the screening period, including: Cholinesterase inhibitors; Spasmolytic; A laxative; Drugs to treat constipation; Tricyclic antidepressants; Any other therapeutic agent that the investigator determines can relieve or treat constipation and its accompanying symptoms. 5) If you are taking dietary fiber or drugs for accompanying diseases such as hypertension, the dose must be stable for at least 30 days and can be maintained until the end of the treatment period; 6) Willing to maintain a stable diet and lifestyle habits, willing and able to complete the scale assessment; 7) For fertile female subjects, the pregnancy test results must be negative and use investigator-approved pregnancy avoidance methods for contraception. The women had to agree to use an investigator-approved method of contraception from the beginning of the screening visit through the end of the study. 8) Participate voluntarily and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1) Combined with organic diseases of the intestine, such as organic diseases of the rectum and colon (tumors, Crohn's disease, colon polyps, intestinal nodules) Constipation caused by intestinal stenosis caused by nuclear, etc., and pain caused by anal lesions that hinder defecation; 2) Inflammatory bowel disease, irritable bowel syndrome, digestive tract tumors, or other systemic diseases involving the digestive tract, such as God Transmuscular lesions, etc., and secondary constipation with clear etiology; 3) Constipation caused by other systemic organic diseases, with a history of abdominal surgery or minimally invasive abdominal surgery; 4) Use of other constipation drugs (including remedial drugs) prescribed in the protocol within 2 weeks before the first treatment period; 5) Stool occult blood positive; 6) Abnormal liver and kidney function (serum alanine aminotransferase and aspartate aminotransferase greater than 1.5 times the normal value, Cr> the upper limit of normal value); 7) Pregnant or pregnant women, breastfeeding women; 8) Allergic physique or allergic to this medicine; 9) Patients with serious primary diseases and mental disorders such as cardiovascular and cerebrovascular, liver, kidney, endocrine, nervous system and hematopoietic system; 10) Participants who have participated in any other interventional clinical trial or received any investigational drug in the 30 days prior to the screening visit; 11) Subjects with other medical conditions or conditions that, in the investigator's opinion, may interfere with compliance with the study protocol, interfere with the evaluation, or cause safety concerns should be excluded if the subject participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total spontaneous defecation (CSBM) response rate at the end of 4 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total spontaneous defecation (CSBM) response rate at the end of 2 weeks of treatment;First CSBM time within 24 hours of first dosing;Average number of complete spontaneous bowel movements (CSBM) per week and their status compared to baseline;Average number of spontaneous bowel movements (SBM) per week and their status compared to baseline;Mean weekly fecal trait scores (using the Bristol Fecal Trait Scale) and compared to baseline;Average weekly defecation effort score compared to baseline;Average number of days per week of remedial drug use;Patient Assessment of Constipation symptom (PAC-SYM);Patient Assessment of Constipation quality of life (PAC- QOL); | — |
Countries
China
Contacts
Public ContactJin Wei
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Outcome results
None listed