All syndrome of Shi Re Huo Du and San Jiao Re Sheng
Conditions
Interventions
experiment group:Huanglian Jiedu Pills, Oral, 2 sachets per dose, 2 times a day
Placebo group:Huanglian Jiedu pill simulants,Oral, 2 sachets per dose, 2 times a day
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Those with throat swelling and pain as main symptoms: (1) Conforming to the TCM syndrome differentiation standard of Shi Re Huo Du syndrome; (2) Meeting the Western diagnosis of acute pharyngitis; (3) Acute onset, and the course of disease is within 48 hours; 2.Those with ulcerations in the mouth and tongue as main symptoms: (1) Conforming to the TCM syndrome differentiation standard of Shi Re Huo Du syndrome; (2) Meeting the Western diagnosis of mild recurrent aphthous ulcer; (3) Acute onset, and the course of disease is within 48 hours; 3. Those with red, swollen, hot and painful gums as main symptoms: (1) Conforming to the TCM syndrome differentiation standard of Shi Re Huo Du syndrome; (2) Meeting the Western diagnosis of gingivitis; 4. Those with dry bound stool as main symptoms: Conforming to the TCM syndrome differentiation standard of Shi Re Huo Du syndrome; 5. Age 18 and above, male or female; 6. Willing to participate in this trial, and sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with precursor or concomitant symptoms of acute infectious diseases (such as measles, scarlet fever, infectious mononucleosis, etc.), suppurative tonsillitis (acute follicular tonsillitis and acute cryptic tonsillitis), abscess around tonsil or abscess of posterior pharyngeal wall, or pharyngeal swallowing pain caused by other diseases; 2. Oral ulcer caused by Behcet's disease or ulcer damage caused by other oral mucosal diseases or tumors; 3. Constipation caused by intestinal stricture as result of intestinal organic diseases (such as tumor, intestinal tuberculosis, etc.), or other systemic diseases involving the digestive tract (such as Parkinson's disease, spinal cord injury, multiple sclerosis, etc.); Or defecation disorder caused by anal diseases; 4. Patients with chronic constipation (such as opioid induced constipation, etc.) or constipation patients caused by other diseases (such as pelvic floor spasm, etc.); 5. Patients combined with severe heart disease (unstable angina pectoris, acute myocardial infarction within 6 months, severe arrhythmia, cardiac function grade IV, etc.), severe respiratory disease (acute attack of bronchial asthma, chronic obstructive pulmonary disease, etc.) or other serious systemic diseases; 6. Patients who have received Chinese and Western medicine or non drug therapy to treat Shi Re Huo Du syndrome and main symptoms, which have been considered by investigators to have an impact on the efficacy evaluation; 7. Body temperature > 38.0 ?, or blood WBC > 11.0 × 10^9/L, or NEUT% > 85%; 8. AST or ALT > 1.5 × ULN, or TBIL > 1.0 × ULN, or Cr > 1.0 × ULN; 9. Patients who had deficiency and cold syndrome in spleen and stomach which is considered not suitable for taking this medicine; 10. Female patients within 5 days (including 5 days) before menstruation; 11. Patients with dysphagia or received gastrointestinal system surgery affecting drug absorption (except appendix surgery); 12. Pregnant women or breast-feeding women and those who have pregnancy plans recently; 13. Patients with disabilities (blind, deaf, dumb, intellectual disability, mental disorders, etc.) as prescribed by law; 14. Poor compliance (those who cannot comply with the log card and regular follow-up specified in the protocol, those who cannot comply with the intervention measures specified in the protocol, and those who plan to accept other disease treatment measures during the trial); 15. Those who have participated in any other clinical trials in the past 1 month; 16. Patients who are considered by investigators not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The treatment effective rate on Shi Re Huo Du syndrome after 5 days of treatment;Vital signs;Routine blood examination, routine urine sediment microscopy , liver function , renal function, 12 lead ECG;The incidence of adverse events/reactions is taken as the primary safety endpoints; | — |
Secondary
| Measure | Time frame |
|---|---|
| The treatment effective rate on acute pharyngitis, recurrent oral ulcer, gingivitis, constipation after 5 days of treatmen;The disappearance rate of main symptoms after 3 and 5 days of treatment;Time of disappearance of main symptoms;The reduction of single syndrome score of Shi Re Huo Du syndrome after 3 and 5 days of treatment, compared with the score of baseline;The reduction of VAS score of acute pharyngitis and throat pain after 3 and 5 days of treatment, compared with the score of baseline;The reduction of VAS score of recurrent oral ulcer pain after 3 and 5 days of treatment, compared with the score of baseline;The change of gingivitis SBI grading score after 3 and 5 days of treatment, compared with the score of baseline;Biomarkers for blood, urine and saliva samples; | — |
Countries
China
Contacts
Public ContactBaohe Wang
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed