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Randomized, double-blind, positive drug parallel controlled, multicenter clinical trial on the efficacy and safety of Re Yan Ning mixture in the treatment of upper respiratory tract infections (wind heat invasion, lung and stomach heat excess syndrome)

Randomized, double-blind, positive drug parallel controlled, multicenter clinical trial on the efficacy and safety of Re Yan Ning mixture in the treatment of upper respiratory tract infections (wind heat invasion, lung and stomach heat excess syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109030
Enrollment
Unknown
Registered
2025-09-10
Start date
2025-09-22
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Upper respiratory tract infection (wind heat invasion, excessive lung and stomach heat syndrome)

Interventions

Experimental group:Re Yan Ning mixture, oral, 20ml once, 3 times a day
Hot Yanning particle simulator, take with boiling water, 2 bags at a time, 3 times a day
Antiviral particle simulator, take with boiling water, 1 bag at a time, 3 times a day.
Control group of similar positive drugs:Antiviral particles, take with boiling water, 1 bag at a time, 3 times a day
Re Yan Ning mixture simulant, oral, 20ml once, 3 times a day
Hot Yanning particle simulator, take with boiling water, 2 bags at a time, 3 times a day.
Control group of positive drugs of the same variety:Hot Yanning granules, take with boiling water, 2 bags at a time, 3 times a day

Sponsors

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meet the Western diagnostic criteria for upper respiratory tract infection; 2. Meet the traditional Chinese medicine diagnostic criteria for wind heat invasion and excessive lung and stomach heat syndrome; 3. Age between 18 and 70 years old (including boundary values), gender not limited; 4. The course of this illness is within 48 hours; 5.Voluntarily participate in the experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Regular use of other medications for the treatment of this disease within 48 hours prior to this visit; 2. Other causes of rhinitis (such as allergic, seasonal, vasomotor, and drug-induced rhinitis), nasal foreign bodies, or foreign body inhalation, as well as abnormal nasal or sinus structures, should be excluded; 3. Respiratory tract infections such as herpetic angina, acute tonsillitis, tracheitis bronchitis, pneumonia, or bronchial asthma, influenza; 4. Patients with spleen and stomach deficiency and cold are prone to diarrhea; 5. Patients with a body temperature of = 38.5 ? during this visit, or those who require concomitant use of antipyretic and analgesic drugs; 6. Combine patients with severe primary diseases of the heart, cerebrovascular, hematopoietic system, and psychiatric disorders; 7. Abnormal liver and kidney function (ALT, AST>1.5 times the upper limit of normal values); Scr>upper limit of normal value; 8. Pregnant or planned pregnant or lactating women; 9. Individuals with allergic constitution or allergies to all drugs or ingredients in this trial; 10. Candidates who have participated in clinical trials of other drugs/devices within one month prior to screening; 11.Researchers believe that individuals who are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Disease recovery time;

Secondary

MeasureTime frame
Severity score of main symptoms - AUC of time;Start cooling time and complete cooling time;Clinical disease recovery rate;The efficacy of traditional Chinese medicine syndrome/disappearance rate of individual symptoms;Time for disappearance of individual symptoms;Usage of antipyretic and analgesic drugs;

Countries

China

Contacts

Public ContactLishan Zhang

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital

lszh111@sina.com+86 133 6636 8125

Outcome results

None listed

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