Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: The TCM diagnostic criteria of Qi-Yin deficiency syndrome (refer to the consensus of TCM experts in diagnosis and treatment of constipation of spleen and stomach Disease Branch of Chinese Society of traditional Chinese Medicine (2017)) the main symptoms are as follows: reduced defecation frequency, prolonged defecation cycle, or difficult fecal quality, difficulty in defecation, or weakness in defecation. Secondary symptoms: Qi deficiency: 1) fatigue and lazy speech; 2) stupefaction; 3) abdominal distension and yin deficiency: 1) hand and foot heart heat; 2) body weight loss; 3) worry and lack of sleep. In line with at least 2 main symptoms, 2 secondary syndromes, qi deficiency and yin deficiency, each disease symptom grading and quantification combined with the guiding principles and related principles of clinical research of new drugs of traditional Chinese medicine. 2.2 Western diagnostic criteria: (1) constipation: the diagnostic criteria are established with reference to the Rome IV diagnostic criteria, as follows: at least 12 weeks in the past 6 months (not necessarily continuous) the following two or more things have occurred: strenuous defecation of more than 11pm; dry knot or hardness of defecation above 21mm4 (refer to Bristol stool trait 1 or 2); and incomplete defecation in defecation of more than 31mm4. 3There is a sense of anorectal obstruction or obstruction when defecation above 41p4, extra help (finger picking, pelvic floor massage) is needed when defecation is above 41x4, spontaneous defecation is less than 3 times a week, and there is no loose defecation, and it is not enough to diagnose irritable bowel syndrome. (2) the history of discontinuation or continuous use of laxatives containing anthraquinones in one year was more than 6 months, and the course of disease was more than 1 year. (3) others: organic diseases were excluded by relevant examination. 2.3 the inclusion criteria meet the diagnostic criteria of western medicine for drug-dependent constipation; the syndrome differentiation of traditional Chinese medicine is deficiency of both qi and yin; the age is from 18 to 70 years old (including 18 and 70 years old); voluntarily participate in this experiment and agree to sign informed consent.
Exclusion criteria
Exclusion criteria: Complicated with organic diseases such as digestive tract, cardiovascular, cerebrovascular, liver, kidney, hematopoietic system and other serious primary diseases; patients with a history of mental illness or mental illness; patients less than 18 years old or more than 70 years old; patients who could not tolerate drug treatment in this study; pregnant and lactating women; any situation considered unsuitable for selection in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-throughput 16SrDNA sequencing and analysis of feces;5-hydroxytryptamine; | — |