Upper Respiratory Tract Infection (Common Cold - Wind-Heat Syndrome)
Conditions
Interventions
Experimental Group:Danmu Extract Syrup + Huan'erhuan Anti-inflammatory Capsules simulator
Controlgroup:Danmu Extract Syrup simulator + Huan'erhuan Anti-inflammatory Capsules
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18–75 years (including boundary values), any gender; (2) Meet the Western medicine diagnostic criteria for upper respiratory tract infection; (3) Meet the traditional Chinese medicine (TCM) syndrome diagnostic criteria for wind-heat syndrome; (4) Disease duration =48 hours at screening; (5) At screening, the highest axillary temperature is 37.3°C = temperature < 38.5°C; (6) Understand and comply with the study procedures, voluntarily participate with full informed consent, and the study participant or guardian signs the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those with concurrent respiratory diseases such as influenza, acute viral or herpetic pharyngitis and laryngitis, acute conjunctivitis, acute bacterial sinusitis, acute tonsillitis, acute exacerbation of allergic rhinitis, acute tracheobronchitis, pneumonia, or other respiratory diseases that may affect the symptom assessment of this study as evaluated by the investigator; (2) Those with venous white blood cell count (WBC) exceeding the upper limit of normal (ULN); (3) Those who, during the current disease episode, have used antibiotics, antiviral drugs, glucocorticoids, antipyretic analgesics, or Western medicines, Chinese patent medicines, Chinese herbal decoction pieces, or non-pharmacological treatments (including but not limited to physiotherapy, acupuncture, moxibustion, scraping, etc.) that are indicated for treating upper respiratory tract infection or for clearing heat, detoxifying, reducing swelling, or relieving pain, or any treatments that may interfere with the study evaluation as assessed by the investigator; (4) Those who are allergic to Danmu Extract Syrup, Huan'erhuan Anti-inflammatory Capsules, rescue medications, or their components, or have a history of definite adverse reactions, or cannot tolerate the study drugs or rescue treatments; (5) Those with severe primary diseases of the heart, brain, lung, liver, kidney, or hematopoietic system, such as malignant tumors, severe malnutrition, uncontrolled hypertension (blood pressure still >140/90 mmHg after medication), etc.; (6) Patients with diabetes mellitus, or with fasting plasma glucose (FPG) =7.0 mmol/L, or random plasma glucose =11.1 mmol/L; (7) Those with abnormal laboratory test results (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN, or renal function (creatinine, Cr) exceeding the ULN) that require further clinical evaluation as assessed by the investigator; (8) Women who are pregnant or breastfeeding, or women with a positive pregnancy test, or individuals (including male participants) with pregnancy plans, or women of childbearing age or their spouses who are unwilling to take effective contraceptive measures during the study; (9) Those who are participating in another clinical study and the time from the last administration of the study intervention to the baseline of this study is less than 3 months, or those who are expected to use other investigational drugs or devices during the study period; (10) Any other conditions considered by the investigator to be unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure Rate of the Disease after 5 Days of Treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Complete Fever Resolution;Time to onset of antipyretic effect;Complete defervescence rate after 3 to 5 days of treatment;Cure Rate of the Disease after 3 Days of Treatment;Cure rate and effectiveness rate of the disease after 3 and 5 days of treatment;The disappearance rate of individual symptoms (chills, fever, nasal congestion, runny nose, sore throat, sneezing, cough, headache, and body aches) after 3 to 5 days of treatment;Changes from baseline in total Traditional Chinese Medicine syndrome scores and individual symptom/sign scores after 3 and 5 days of treatment;Efficacy of Traditional Chinese Medicine (TCM) syndrome treatment over 3–5 days, cure rate, significant improvement rate, and overall effective rate for individual TCM symptoms/signs;Number of cases of emergency medication, number of persons using the medication, average dosage, and average duration of medication during the study period; | — |
Countries
China
Contacts
Public ContactZhanShaofeng
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed