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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.

Not Applicable
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
Inclusion Criteria

(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.

Exclusion Criteria

(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
NameTimeMethod
Time to complete fever resolution (hours) (body temperature = 37.2°C for more than 24 hours);
Secondary Outcome Measures
NameTimeMethod
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;
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