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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000317
Enrollment
Unknown
Registered
2024-08-27
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory viral infection

Interventions

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Body temperature (axillary temperature) = 37.3?; (2) Meets the diagnostic criteria for acute respiratory viral infection; (3) Meets the diagnostic criteria for traditional Chinese medicine fever (specifically rheumatic exterior syndrome and heat attacking the lung-wei syndrome); (4) Age between 18 and 65 years, no gender restriction; (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; (6) Willing to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Combined with tumor diseases, immunodeficiency diseases, immune disorders, or other diseases affecting body temperature; (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); (3) Women who are planning pregnancy, pregnant, breastfeeding, or unable to strictly use contraception during the study period; (4) Intellectual disabilities, mental disorders; (5) Known allergy to ingredients of the Chinese medicine prescription or inability to comply with medical instructions for treatment; (6) Participation in other clinical trials within the last month.

Design outcomes

Primary

MeasureTime frame
Time to complete fever resolution (hours) (body temperature = 37.2°C for more than 24 hours);

Secondary

MeasureTime frame
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;Usage rate of emergency antipyretic medication (acetaminophen), per capita usage (units: mg);Time to fever reduction onset (hours) (time taken for body temperature to first decrease to 37.2°C after treatment);

Countries

China

Contacts

Public ContactZanfei,Tan

Wangjing Hospital, China Academy of Chinese Medical Sciences

1015686953@qq.com+86 159 0128 0329

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026