Constipation
Conditions
Interventions
Test group:Tongli enteric coated capsules oral 4 capsules each time bid. Medication for 1 week
Control group:Tongli enteric coated capsule mimetic agent,oral, 4 capsules each time, bid. Medication for 1 week
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for constipation in traditional Chinese medicine; 2. Meet the diagnostic criteria for heat accumulation and constipation; 3. Have not taken any medication to treat constipation within the two weeks prior to enrollment and have had less than three spontaneous bowel movements in the first week prior to enrollment; 4. Age range from 18 to 65 years old (including boundary values) regardless of gender; 5. The subject has understood the trial content and voluntarily signed an informed consent form and the process of obtaining informed complies with GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed by researchers with constipation caused by intestinal stenosis caused by organic lesions of the intestine (such as obstructive diseases gastrointestinal tumors inflammatory bowel diseases intestinal tuberculosis etc.) or severe organic lesions of the anus causing defecation disorders; 2. Drug related constipation patients: those who regularly use drugs that are clearly stated in the drug instructions to cause constipation in the first 4 weeks of screening such as antispasmodic drugs antidiarrheal drugs non steroidal anti-inflammatory drugs etc. or those who cannot stop using these drugs during the study period; 3. Patients with severe primary diseases such as heart lung kidney brain hematopoietic endocrine system and malignant tumors; 4. Individuals who have undergone abdominal surgery within the first three months or plan to undergo abdominal surgery during the trial period; 5. ALT AST or TBIL>1.5 times the upper limit of normal value or Scr>the upper limit of normal value; 6. Individuals who have allergies or allergic constitutions to known drug components (such as allergies to two or more drugs or foods); 7. Individuals with psychological mental or cognitive abilities language expression abilities or a history of mental illness who have been assessed by researchers as unable to cooperate in completing clinical trials such as those with severe depression or anxiety disorder; 8. Suspect or have a history of alcohol or drug abuse; 9. Suspect or indeed have dietary disorders such as anorexia bulimia etc; 10. Pregnant and lactating female patients male subjects and female subjects with fertility who are unwilling or unable to use effective contraceptive measures during the trial period; 11. Individuals who have participated in clinical trials of other drugs within the first three months; 12. Researchers believe that colonoscopy is necessary to exclude malignant lesions; 13. Researchers believe that patients with warning signs (such as anemia fatigue emaciation abdominal masses etc.) need further examination to exclude those with organic diseases; 14. Other situations that the researcher deems unsuitable for participation in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of complete spontaneous bowel movements (CSBM) after one week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The dosage of the remedial drug Glycerol Enema after the first use of medication;Changes in the integral of Rejimi symptoms;Number of assisted bowel movements;Changes in fecal trait scores;The therapeutic effect of traditional Chinese medicine syndrome integration; | — |
Countries
China
Contacts
Public ContactFengbin Liu
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed