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Randomized, double-blind, parallel to the positive control drug and a placebo controlled, multicenter clinical re-evaluation trial of efficacy and safety of Yi qing capsule in the treatment of toxic heat syndrome (acute tonsillitis, acute pharyngitis, marginal gingivitis, recurrent aphthous)

Randomized, double-blind, parallel to the positive control drug and a placebo controlled, multicenter clinical re-evaluation trial of efficacy and safety of Yi qing capsule in the treatment of toxic heat syndrome (acute tonsillitis, acute pharyngitis, marginal gingivitis, recurrent aphthous)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013835
Enrollment
Unknown
Registered
2017-12-12
Start date
2008-12-01
Completion date
Unknown
Last updated
2017-12-18

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

Conditions

Acute pharyngitis

Interventions

placebo controlled group:placebo
Experiment groups:Yi Qing Capsule
the positive control drug group:Niuhuang Jiedu Wan

Sponsors

The Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Accord with standard of toxic heat syndrome of TCM, in line with the western medicine diagnostic criteria of acute pharyngitis; Aged 18 to 65 years old; Patients' informed consent and signed informed consent

Exclusion criteria

Exclusion criteria: 1. The temperature 38.5 degree , and/or WBC > 11.0 x 10^9/L, and/or N % > 85% 2. Pharyngeal symptoms or inflammation induced by scarlet fever, measles, influenza and agranulocytosis, infectious mononucleosis and leukemia. 3. The combination of pneumonia, bronchitis, respiratory diseases such as acute laryngitis, epiglottitis; 4. A history of rheumatic fever, history of drug or alcohol abuse; 5. Use of other drugs to treat the disease (including analgesia anti-inflammatory drugs); 6. Complication of serious primary diseases, such as heart, liver, kidney and hematopoietic system, such as serum creatinine than normal (133 mu mol/L), and/or urine protein > +, and/or urine RBC > +;Serum Alt > 1.5 times that of the upper limit of normal value;Have clinical significance of arrhythmia, such as diabetes patients mentally or legal disability; 7. Nearly three months in patients with other drugs in clinical trials; 8. Two or more food or drug allergies; 9. Pregnancy and inclination to pregnancy or breast-feeding women; 10. A taboo or tolerance in the presence of rhubarb, Scutellaria, and Coptis.

Design outcomes

Primary

MeasureTime frame
The total number of white blood cells;

Countries

China

Contacts

Public ContactDehui Wang

The Eye and ENT Hospital of Fudan University

gaonaeent@126.com+86 021-64377134-202

Outcome results

None listed

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