Wind and Fire Toothache Syndrome (Periodontitis / Pericoronitis)
Conditions
Interventions
Test group:Toothache Stopping Pills, 2 pills per time, apply to the affected area, 3 times a day.
Dingxi Toothache Capsule Simulant, 4 pills per time, 3 times a day, take with plain water after meals.
Placebo group:Ding Xi Yage Capsules, 4 capsules per dose, 3 times a day. Take with warm water after meals.
Dai Chang Di Drip Pills Simulant, 2 pills per dose, apply to the affected area, 3 times a day
Sponsors
Dongfang Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 65 years (including age boundaries), no gender restrictions; 2) Meet the diagnostic criteria for Western medicine periodontitis or pericoronitis (refer to Tan Jin's edited 'Integrative Chinese and Western Medicine Oral Science'); 3) Meet the diagnostic criteria for Traditional Chinese Medicine for wind-heat toothache syndrome (refer to Tan Jin's edited 'Integrative Chinese and Western Medicine Oral Science'); 4) Clinical presentation mainly includes toothache, VAS score >= 4, untreated; 5) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Known or suspected history of allergy to the experimental drug and its excipients or severe adverse reactions; 2) Coexisting upper respiratory infections; 3) Accompanied by fever (body temperature > 38.5?); 4) Blood routine white blood cell count > 15×10^9/L; 5) Patients who may require tooth extraction during treatment; 6) Patients with other significant oral lesions that may affect the observation of efficacy, such as acute pulpitis, acute apical periodontitis, oral ulcers, and space infections caused by carious lesions, trauma, occlusal injuries, or cracks; 7) Use of analgesics within 24 hours prior to medication; traditional Chinese medicine and Western medicine that may affect evaluation within 48 hours as judged by the investigator; 8) Presence of orthodontic devices in the mouth; 9) Coexisting severe liver and kidney diseases or abnormal liver and kidney function tests (ALT, AST >= 1.5 times the upper limit of normal, Scr > upper limit of normal); 10) Coexisting severe cardiovascular and cerebrovascular diseases (such as NYHA functional classification III-IV congestive heart failure, myocardial infarction, acute stroke); uncontrolled hypertension (sitting systolic blood pressure >= 160mmHg or diastolic blood pressure >= 100mmHg after receiving the best antihypertensive treatment); poor blood sugar control (fasting blood sugar > 8.5mmol/L); 11) Coexisting autoimmune diseases, malignant tumors, severe respiratory, blood, and hematopoietic system diseases; 12) Patients with neurological and psychiatric disorders who are unable or unwilling to cooperate, or those with suicidal tendencies; 13) Suspected or confirmed tendency for alcohol or drug abuse or dependence; 14) Pregnant or breastfeeding women, or those with recent reproductive plans (including female partners of male participants); 15) Participation in other clinical trials within 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for pain relief to take effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| The effective rate of pain relief within 1 hour, 2 hours after the first administration and within 1, 2, 3 and 5 days after the treatment.;Changes in VAS pain scores at the time of onset of analgesic effect and at each time point after the first administration compared with baseline;The disappearance rate of pain within 2 hours after the first administration and within 1, 2, 3 and 5 days after the treatment;The therapeutic effect of traditional Chinese medicine on the syndrome after treatment;The percentage of invalid qualified cases; | — |
Countries
China
Contacts
Public ContactMu Hong; Luo Siyue
Dongfang Hospital of Beijing University of Chinese Medicine
Outcome results
None listed