Clinical Study on the Treatment of Adult Fever (syndrome of superficies obstructing by wind-dampness, and heat invading the lung defensive qi) with Kang Du Tui Re Formula.
- Conditions
- Acute respiratory viral infection
- Registration Number
- ChiCTR2400088878
- Lead Sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Body temperature (axillary temperature) = 37.3?;<br>(2) Meets the diagnostic criteria for acute respiratory viral infection;<br>(3) Meets the diagnostic criteria for traditional Chinese medicine fever (specifically rheumatic exterior syndrome and heat attacking the lung-wei syndrome);<br>(4) Age between 18 and 65 years, no gender restriction;<br>(5) Time from the first appearance of symptoms (or confirmed onset of illness) to randomization for medication does not exceed 48 hours, and no prior treatment has been administered;<br>(6) Willing to participate in this clinical trial and sign an informed consent form.
(1) Combined with tumor diseases, immunodeficiency diseases, immune disorders, or other diseases affecting body temperature;<br>(2) Combined with severe primary diseases of the cardiovascular, cerebrovascular, liver, kidney, hematopoietic, and endocrine systems, or immune system diseases (liver function ALT, AST > 1.5 times the upper limit of normal reference values, Scr > upper limit of normal reference values, poor blood glucose control);<br>(3) Women who are planning pregnancy, pregnant, breastfeeding, or unable to strictly use contraception during the study period;<br>(4) Intellectual disabilities, mental disorders;<br>(5) Known allergy to ingredients of the Chinese medicine prescription or inability to comply with medical instructions for treatment;<br>(6) Participation in other clinical trials within the last month.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to complete fever resolution (hours) (body temperature = 37.2°C for more than 24 hours);
- Secondary Outcome Measures
Name Time Method Time to fever reduction onset (hours) (time taken for body temperature to first decrease to 37.2°C after treatment);Usage rate of emergency antipyretic medication (acetaminophen), per capita usage (units: mg);Symptom scores for individual symptoms (fever, fatigue, cough, body aches, taste and smell abnormalities, diarrhea, nasal congestion, runny nose, headache, fatigue) before treatment, on day 3, and day 6 post-treatment: absolute values and changes.;TCM (Traditional Chinese Medicine) syndrome score;Time to virus negativity;