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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 acute tonsillitis (wind heat invasion, lung 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 acute tonsillitis (wind heat invasion, lung stomach heat excess syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108724
Enrollment
Unknown
Registered
2025-09-04
Start date
2025-10-09
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Acute tonsillitis (wind heat invasion, excessive lung and stomach heat syndrome)

Interventions

Experimental group:Reyanning mixture, orally, 20ml at a time, 3 times a day, shake well when used
Reyanning granule simulant, wash with boiling water, 2 bags at a time, 3 times a day
Pudilan anti-inflammatory oral solution mimic, orally, 1 stick at a time, 3 times a day.
Control group of similar positive drugs:Pudilan anti-inflammatory oral solution, orally, 1 bottle at a time, 3 times a day
Reyanning mixture simulant, orally, 20ml at a time, 3 times a day, shake well when used
Reyanning granule simulant, washed with boiling water, 2 bags at a time, 3 times a day.
Control group of positive drugs of the same variety:Reyanning granules, wash 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 65 Years

Inclusion criteria

Inclusion criteria: 1. Meets the Western diagnostic criteria for acute tonsillitis; 2. Meet the traditional Chinese medicine diagnostic criteria for wind heat invasion and excessive lung and stomach heat syndrome; 3. Age range of 18 to 65 years old (including boundary values), gender not limited; 4. The acute course of the disease is within 48 hours; 5. Visual Analog Scale (VAS) for sore throat intensity >= 40 mm; 6. The informed consent process complies with regulations and voluntarily signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Symptoms or inflammation of the throat caused by diseases such as diphtheria, scarlet fever pharyngitis, herpetic pharyngitis, tuberculous pharyngitis, tonsillar tumors, neutropenic pharyngitis, leukemia pharyngitis, etc; 2. Patients with a body temperature of >= 38.5 ? during this visit, or those who require concomitant use of antipyretic and analgesic drugs; 3. Patients who have developed local or systemic complications (such as retropharyngeal abscess, parapharyngeal abscess, peritonsillar abscess, myocarditis, infectious laryngitis, bacterial otitis media, acute rhinosinusitis, acute bronchitis, pneumonia, rheumatic fever, acute glomerulonephritis, acute arthritis, etc.); 4. Those who have used other traditional Chinese and Western medicines for the treatment of this disease within 48 hours before this visit; 5. Patients with spleen and stomach deficiency and cold are prone to diarrhea; 6. For those with a white blood cell count (WBC) >= 15 × 10^9/L, antibiotic treatment should be considered. 7. Abnormal liver and kidney function (ALT, AST>1.5 times the upper limit of normal values); Scr>upper limit of normal value; 8. Patients who require tonsillectomy due to tonsillitis; 9. Individuals with allergic constitution or allergies to all drugs or ingredients in this trial; 10. Combine patients with severe primary diseases of the heart, cerebrovascular, hematopoietic system, and psychiatric disorders; 11. Pregnant or planned pregnant or lactating women; 12. People with organ transplantation, AIDS, long-term use of immunosuppressants and other immune deficiencies; 13. Screening participants who have participated in clinical trials of other drugs/devices within the previous month; 14. Researchers believe that individuals who are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Recovery time of acute tonsillitis disease;

Secondary

MeasureTime frame
Rate of disappearance of sore throat;The onset time and disappearance time of sore throat;The change in VAS score of sore throat compared to baseline;Start cooling time and temperature recovery time;Disease recovery rate;The efficacy of traditional Chinese medicine syndrome/disappearance rate of individual symptoms;The disappearance time of individual symptoms in traditional Chinese medicine;The use of antipyretic and analgesic drugs;Incidence of complications;

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