acute pharyngitis (syndrome of exuberant heat in lung and stomach)
Conditions
Interventions
Experimental group:Kaihoujian spray, 8 sprays per time, 8 times per day, spray on the affected part. Banzhilian tablets simulant, 5 tablets at a time, 3 times a day, orally.
Positive control group:Kaihoujian spray simulant, 8 sprays per time, 8 times per day, spray on the affected area. Banzhilian tablets, 5 tablets at a time, 3 times a day, orally.
Sponsors
Dongfang Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age range of 18-65 years old (including 18 and 65 years old), gender is not limited; (2) Meets the diagnostic criteria for acute pharyngitis in Western medicine; (3) Meets the syndrome differentiation criteria of traditional Chinese medicine for syndrome of exuberant heat in lung and stomach; (4) The onset time before the first medication is less than 48 hours; (5) Pharyngeal pain (swallowing pain) VAS score = 40mm; (6) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known or suspected allergy to the components of the investigational drug, or allergic constitution. (2) Pharyngeal symptoms or inflammation caused by other diseases such as measles, scarlet fever, influenza, granulocyte deficiency, infectious mononucleosis, leukemia, acute carotid arteritis, etc. (3)Merge diseases that affect efficacy evaluation, including but not limited to pneumonia, bronchitis, suppurative tonsillitis, infectious laryngitis, and bacterial otitis media. (4) When screening, the body temperature (armpit temperature) should be = 38.5 ?. (5) Abnormal values of white blood cells and neutrophils (greater than the upper limit of normal by 20%), suspected bacterial infection by researchers. (6) Alcohol allergy sufferers. (7) The following treatments that affect the evaluation of the trial must be combined during the current use or expected trial period, including but not limited to: 1) Traditional Chinese medicine preparations or decoctions such as Qingyan Lihou Granules, Erding Granules, Qingyan Dripping Pills, Banzhilian Capsules, Shuangyang Houbitong Granules, Yuhechao Tablets, etc., which have the effect of treating acute pharyngitis or sore throat. 2) Duobeier's solution, Dumifen lozenges, Xidi iodine lozenges, lysozyme lozenges and other chemical preparations with therapeutic effects on acute pharyngitis. 3) Antibiotic, antiviral, hormone and other treatment measures. (8) Before screening, analgesics or other Chinese and Western medicines with acute pharyngitis and sore throat treatment effects have been used. (9) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are = 1.5 times the upper limit of normal values, and blood creatinine (Scr) is>the upper limit of normal values. (10) Merge with serious primary diseases such as cardiovascular, hepatic, renal, and hematopoietic systems. (11) Merge with uncontrolled hypertension (history of hypertension at screening, currently receiving regular medication treatment, blood pressure measured twice continuously at screening = 160/100mmHg). (12) Patients with diabetes. (13) Individuals with a history of digestive system disorders that affect oral drug absorption. (14) History of malignant tumors within 5 years prior to the first administration, excluding cervical epithelial cancer, squamous cell carcinoma, or basal cell carcinoma of the skin that achieved clinical cure within 5 years of diagnosis. (15) Suffering from immunodeficiency. (16) Having neurological or mental disorders that prevent or hinder cooperation. (17) Suspect or confirm a history of alcohol, drug, or substance abuse. (18) Pregnant women, breastfeeding women, or those who have recently planned to have children. (19) Participated in other interventional clinical trials within the past 3 months. (20) Researchers believe that participants cannot participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The disappearance rate of pharyngeal pain (swallowing pain) after medication.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The onset rate of sore throat (swallowing pain) immediately after medication (within 5 minutes), 10 minutes after medication, 20 minutes after medication, and 30 minutes after medication.;The disease recovery rate after the end of medication.;The changes in VAS scores for sore throat (swallowing pain) compared to baseline for each visual analog scale (VAS) scoring point.;Changes in the total score and individual scores of the pharyngeal sign evaluation form compared to baseline after the end of medication.;Changes in Traditional Chinese Medicine Syndrome Score from Baseline after the end of medication.;The recovery rate, significant improvement rate, and total effective rate of traditional Chinese medicine syndromes after the end of medication.;The disappearance rate of each individual symptom of traditional Chinese medicine syndrome after 3 days of medication and after the end of medication.; | — |
Countries
China
Contacts
Public ContactWang Jiaxi
Dongfang Hospital, Beijing University of Chinese Medicine
Outcome results
None listed