A multicenter, randomized, double-blind, placebo-controlled exploratory clinical trial for efficacy and safety of Simo Decoction in the treatment of functional constipation (qi stagnation)
- Conditions
- Functional constipation (air stagnation)
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Meet the western and Chinese diagnostic criteria for functional constipation (qi stagnation);
(2) Those aged between 18 and 65 (both ends included);
(3) Less than 3 times a week of fully spontaneous defecation;
(4) Colonoscopy results were generally normal;
(5) The subject is informed and voluntarily signs the informed consent;
(6) Resident in local area, able to guarantee treatment follow-up, with certain reading ability.
(1) constipation caused by organic diseases (such as colon tumor, intestinal stenosis or obstruction, etc.);
(2) endocrine and metabolic diseases such as diabetes and hypothyroidism;
(3) drug-related constipation (such as opioids, etc.);
(4) Patients with serious lesions of heart, liver and kidney, hematopoietic system diseases, nervous system diseases, muscle diseases and other system tumors;
(5) have a history of mental illness (such as severe depression, severe anxiety);
(6) Pregnant or lactating women who had a birth plan from enrollment to 1 month after the end of the study;
(7) suspected or confirmed history of alcohol or drug abuse;
(8) allergic to the test drug, emergency drug and its ingredients;
(9) Patients who have participated in other clinical trials or are currently participating in other clinical trials within 1 month prior to inclusion;
(10) the investigator considers it inappropriate to conduct clinical trials.
Study & Design
- Study Type
- Observational study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Emergency drug use;Symptoms associated with defecation;complete spontaneous bowel movement;TCM syndrome integral;Patient report clinical outcome evaluation Scale;
- Secondary Outcome Measures
Name Time Method