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Multi-center and practical randomized controlled clinical trial on the safety and effectiveness of acupoint application of traditional Chinese medicine in the treatment of influenza-like fever and pharyngalgia (external cold and internal heat syndrome)

Multi-center and practical randomized controlled clinical trial on the safety and effectiveness of acupoint application of traditional Chinese medicine in the treatment of influenza-like fever and pharyngalgia (external cold and internal heat syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070510
Enrollment
Unknown
Registered
2023-04-14
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Influenza-like disease

Interventions

Test group:Acupoint application combined with conventional western medicine

Sponsors

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Conform to the diagnostic criteria for influenza like cases in the Diagnosis and Treatment Plan for influenza (2020); (2) Conform to the diagnostic criteria of the syndrome of external cold and internal heat in traditional Chinese medicine; (3) Have symptoms of fever and sore throat, either or both; The standard of fever is axillary temperature = 38 ?, and the standard of pharyngalgia is pharyngalgia visual analogue score (VAS) = 3 points when swallowing; (4) Time of onset < 72h; (5) Age 18 - 65 (including both ends), gender unlimited; (6) Informed consent of patients, volunteers and signed informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those who meet the diagnostic criteria for severe and critical influenza in the Diagnosis and Treatment Plan for influenza (2020 Edition); (2) In line with the influenza Diagnosis and Treatment Plan (2020 Edition), people at high risk of severe/critical influenza: ? Those with the following diseases or conditions: chronic respiratory system disease, cardiovascular system disease (except hypertension), kidney disease, liver disease, blood system disease, nervous system and neuromuscular disease, metabolic and endocrine system disease, malignant tumor, immune function inhibition, etc; ? Obese people [body mass index (BMI) greater than 30]; ? Pregnant and perinatal women. (3) Influenza-like symptoms caused by other diseases; ? (4) Subjects have received antiviral treatment before entering the study; (5) Subjects were treated with traditional Chinese medicine or proprietary Chinese medicine before enrollment; (6) Subjects who plan to be pregnant or pregnant, lactating or lactating; (7) Subjects with skin lesions on the application site, such as scars and ulcers; (8) Subjects with autonomic nervous dysfunction with abnormal sweat secretion; (9) Psychotic patients; (10) Subjects who are allergic to the known test drug; (11) Subjects who are participating in other clinical trials or receiving similar external treatment intervention.

Design outcomes

Primary

MeasureTime frame
Antipyretic onset time;Antipyretic time;Time of disappearance of pharyngalgia;

Secondary

MeasureTime frame
Heat disappearance rate;Pharyngeal pain disappearance rate;Incidence rate of progression to severe/critical severe within 5 days;Elimination rate of other symptoms;

Countries

China

Contacts

Public ContactRui Gao

Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine

ruigao@126.com+86 13911097756

Outcome results

None listed

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