Keganliyan oral liquid in the treatment of acute pharyngitis (externally induced wind-heat syndrome) : a randomized, double-blind, placebo-parallel, multicenter clinical study

Phase 4

Recruiting

• Conditions: Acute Pharyngitis

• Registration Number: ITMCTR2200005711
• Lead Sponsor: Guangdong Provincial Hospital of traditional Chinese medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) meet the diagnostic criteria of acute pharyngitis of Western Medicine;
(2) meet the diagnostic criteria of wind-heat Syndrome caused by exogenous pathogenic factors of Traditional Chinese Medicine;
(3) body temperature =38.5 °c;
(4) Pain Vas =4 points;
(5) course of Disease =48 hours;
(6) age between 18 and 65 years;
(7) sign voluntary informed consent.

Exclusion Criteria

(1) patients with NCP positive for nucleic acid or suspected positive for imaging;
(2) patients with suppurative Tonsillitis, pneumonia, bronchitis, otitis media, Herpangina, viral myocarditis, acute nephritis, rheumatic joints and other diseases;
(3) as a result of measles, scarlet fever, influenza and Agranulocytosis, infectious mononucleosis, leukemia and other pharyngeal symptoms or inflammation;
(4) white blood cell count (WBC)=10 * 10 ^ 9/l;
(5) those who have used other Chinese and Western medicine for this disease or need to take antibiotics for other diseases within 24 hours;
(6) patients with severe primary diseases of heart, cerebral vessels and hemopoietic system, in which AST, ALT > 1.5 n (n is the upper limit of normal value) , serum creatinine (CR) > the upper limit of normal value; patients with malignant tumor;
(7) patients with neurological and mental disorders who can not cooperate, or unwilling to cooperate;
(8) Allergic Constitution or allergic history to more than two drugs or known ingredients of the drug;
(9) pregnant and expectant pregnant or lactating women;
(10) participated in other clinical trials in the last 3 months;
(11) the researchers did not consider it appropriate to participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total disease response rate;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score change value;Cough VAS score changes;Single symptom score change value;VAS score of pharyngeal pain;Time of onset of sore throat;Time for sore throat to disappear/Disappearance rate of sore throat;Time for complete fever reduction;Area under the pharyngeal VAS score curve;Use of palliative drugs;