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Clinical reappraisal study for multi-target regulation of different doses of Pudilan Xiaoyan oral liquid on adult acute pharyngitis and tonsillitis

Clinical reappraisal study for multi-target regulation of different doses of Pudilan Xiaoyan oral liquid on adult acute pharyngitis and tonsillitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025731
Enrollment
Unknown
Registered
2019-09-06
Start date
2019-10-01
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

acute pharyngitis and tonsillitis

Interventions

Sponsors

Liaonig Provincial Academy of Traditional Chinese Medicine/ the Second Hospital Affiliated to Liaoning University Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) To meet the diagnostic criteria of acute pharyngitis and/or tonsillitis; (2) It conforms to the diagnostic criteria of sign of external wind-heat offence lung and excessive heat of lung and stomach in TCM; (3) Aged 18-65 years; (4) In the bacterial infection group:WBC >= 10x10^9/L, SAA >= 10mg/L, CRP>= 10mg/L; (5) In the non-bacterial infection group: WBC= 10mg/L, CRP<10mg/L; (6) No other antibiotics or other antipyretic and detoxifying drugs for pharyngitis /tonsillitis were taken within 48 hours before admission. (7) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Complicated with suppurative tonsillitis, pneumonia, bronchitis, otitis media, herpetic angina, viral myocarditis, acute nephritis, rheumatic arthritis and other diseases; (2) WBC>15x10^9/L; (3) Liver and kidney dysfunction, ALT and AST were two times higher than the normal upper limit, BUN and Cr were higher than the normal upper limit. (4) Allergic constitution, allergic to all drugs and penicillins in this test; (5) Patients with serious primary diseases of heart, cerebrovascular and hematopoietic system and psychosis; (6) Pregnant or planned pregnancy or lactation women; (7) People with immunodeficiency such as organ transplantation, AIDS and long-term use of immunosuppressive agents; (8) Because of intellectual or behavioral disorders, they can not cooperate with clinical observers. (9) Who participating in other clinical trials which will influence evaluating the results of this study.

Design outcomes

Primary

MeasureTime frame
Total effective rate of pharyngalgia;

Secondary

MeasureTime frame
??????????? Time of onset and disappearance of pharyngalgia;VAS score of pharyngalgia;Body temperature (initial antipyretic time, complete antipyretic time and temperature normalization rate);The disappearance rate of single symptom;Cure rate of disease;Time/dose of antibiotics;Negative rate of common bacteria culture (pharyngeal swab) (only tested in bacterial infection group);Laboratory indicators: SAA, CRP, ESR, blood routine (total white blood cells, percentage of neutrophils);

Countries

China

Contacts

Public ContactGuoxin Li

Liaonig Provincial Academy of Traditional Chinese Medicine/ No.2 Hospital Affiliated to Liaoning University Traditional Chinese Medicine

fbyjsln@163.com+86 13390582999

Outcome results

None listed

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