Constipation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) According to the Rome IV diagnostic criteria for functional constipation and constipation of deficiency of qi and fluid; (2) During the lead-in period (1 week) , less than 3 times of spontaneous defecation; (3) Aged 60 or above; (4) Volunteer to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)constipation caused by intestinal stricture caused by organic pathological changes of rectum and colon (such as tumor, inflammation, Crohn's disease, intestinal adhesion, colon polyp, colon tuberculosis, etc.) ; (2)constipation caused by Hirschsprung's disease (HD) , neurological disorders (e.g. autonomic neuropathy, cerebrovascular disease) , mental disorders, metabolic and endocrine disorders (e.g. hypothyroidism, diabetes) , muscular diseases (e.g. amyloidosis, dermatomyositis) , etc. (3)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (4)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (5)drug-related constipation, such as antidepressants, antiepileptic drugs, antihistamines, anticonvulsants, antipsychotic, antispasmodic drugs, calcium antagonists, diuretics, Monoamine oxidase inhibitor, opioids, Sympathomimetic drug, antacids containing aluminium or calcium, calcium, iron, antidiarrheals, non-steroidal anti-inflammatory drug, etc. (6)allergic to the components of this preparation; (7)patients with severe cardiovascular and cerebrovascular diseases (such as hypertension and coronary heart disease) , liver, kidney and hematopoietic system diseases (8)patients with anxiety, depression or tendency (9)pregnant or lactating women, (10) patients treated with laxative drugs in the last 2 weeks (11) patients who have participated in other clinical trials in the last 1 month (12)researchers consider it inappropriate to participate in clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation;Quantitative score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, including vital signs; | — |
Countries
China
Contacts
The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine