Functional constipation
Conditions
Interventions
Control group:Oral solution of lactulose, initial dose of 30 ml daily total dose, 1 sachet of 15 ml once, 2 times a day, maintenance dose of total daily dose of 15 ml, 1 bag at a time, once a day, ora
Experimental group:First Laxative Capsules, 0.35g per capsule, oral, 2 capsules at a time, 3 times daily for 2 weeks, after 1 week of discontinuation, continue for 2 weeks
the course of treatment is 4 weeks
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Roman IV diagnostic criteria for functional constipation; (2) Meet the diagnostic criteria of Constipation Qi Yin and Yin In Traditional Chinese Medicine; (3) Age 40-75 years old, male or female; (4) Voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) History of related intestinal diseases that may cause constipation or intestinal stenosis in the past, such as small intestine and colorectal lesions (such as tumors, inflammation, fissures, clonal diseases, ulcerative colitis, intestinal adhesions, colon polyps, intestinal tuberculosis, large intestine, etc.). (2) Malignant tumors of the digestive system or other systemic diseases affecting the digestive system, such as myasthenia gravis. (3) Caused by Hirschsprung's disease, neurological disorders, mental disorders, diabetes, metabolic endocrine disorders (such as thyroid lesions, etc.). (4) Constipation caused by organic lesions of the whole body. (5) People with functional defecation disorders. (6) Those who are allergic to the constitution or are allergic to the composition of this preparation (lactulose). (7) Complicated by serious diseases such as cardiovascular and cerebrovascular diseases, liver, kidneys, nervous system and hematopoietic system. (8) Those who have received systemic constipation treatment and used laxative drugs in the past 2 weeks. (9) Patients who have participated in other clinical trials in the past three months. (10) Exclude the possibility that taking medication may cause constipation, such as opioids. (11) Pregnant and lactating women, and those who have a childbirth or breastfeeding plan within half a year. (12) Previously diagnosed with anxiety-depressive symptoms or tendencies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total effective rate of treatment: total effective rate = (effective + effective) number of cases / total number of cases ×1 00%; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel onset time;Evaluation of stool traits;The number of completely spontaneous bowel movements (CSBM) per week;Quality of life evaluation;TCM evidence of therapeutic effect;Frequency of bowel movements;Frequency of spontaneous bowel movements in the 12th week after the first dose; | — |
Countries
china
Contacts
Public Contactenhuayang
Outcome results
None listed