Acute upper respiratory tract infection (wind-heat pattern)
Conditions
Interventions
Experimental Group:Shu Feng Jie Du Capsules, oral, 4 capsules per dose, 3 times daily.
Placebo control group:Shufeng Jiedu Capsule Simulant, oral administration, 4 capsules per dose, three times daily.
Sponsors
Hebei Provincial Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for acute upper respiratory tract infection in Western medicine; (2) Meets the diagnostic criteria for the wind-heat pattern in Traditional Chinese Medicine (TCM); (3) Aged between 18 and 70 years (inclusive), with no restriction on gender; (4) The duration of the current illness is within 48 hours; (5) The visual analog scale (VAS) score for throat pain is =40mm; (6) Voluntarily participates in the trial and signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have regularly used other Chinese and Western medications for treating this condition within 48 hours prior to this visit (including but not limited to: antipyretic analgesics such as paracetamol, ibuprofen, etc.; antihistamine and decongestant combination medications such as pseudoephedrine hydrochloride, etc.; Chinese and Western medications for alleviating cold symptoms, such as Mefenamic Acid Pseudoephedrine Tablets, Compound Paracetamol Pseudoephedrine Sustained-Release Capsules, Lianhua Qingwen Capsules, etc.); (2) Patients who have other causes of rhinitis (such as allergic, seasonal, vasomotor, or drug-induced rhinitis), nasal foreign bodies, or foreign body aspiration, as well as nasal or paranasal sinus structural abnormalities; (3) Patients with concurrent herpangina, acute tonsillitis, tracheobronchitis, pneumonia, or other respiratory tract infections, or concurrent bronchial asthma, COPD, interstitial fibrosis, or influenza; (4) Patients with a body temperature (axillary) =38.5°C at the time of this visit; (5) Patients with severe underlying diseases in the cardiovascular, respiratory, cerebrovascular, endocrine, digestive, or hematopoietic systems, or patients with mental illness; (6) Patients with a white blood cell count >1.2 times the upper limit of normal; (7) Patients with ALT and AST >1.5 times the upper limit of normal, or Scr > upper limit of normal; (8) Pregnant or planning to become pregnant, or breastfeeding women; (9) Patients with allergic constitutions (e.g., allergic to three or more drugs or foods) or allergic to any of the medications or components in this trial; (10) Patients who have participated in other drug/device clinical trials within the past month prior to screening; (11) Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to recovery from illness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Onset time of sore throat relief;Time of sore throat disappearance;Primary Symptoms Severity Score - Time AUC;Onset of defervescence;Complete defervescence time;The cure rate of clinical diseases after the treatment period of full 3 days and full 5 days.;The disappearance rate of individual symptoms after 3 days and 5 days of treatment.;Time to resolution of specific symptoms;Traditional Chinese Medicine symptom efficacy;Usage of Antipyretic and Analgesic Drugs; | — |
Countries
China
Contacts
Public ContactWu Lei
Hebei Provincial Traditional Chinese Medicine Hospital
Outcome results
None listed