Efficacy and safety of Chai Yin granules for the treatment of influenza(exogenous wind-heat syndrome): a randomized, double-blind, positive drug control, multicenter clinical trial

Phase 4

• Conditions: Influenza

• Registration Number: ITMCTR2100004720
• Lead Sponsor: China-Japan Friendship Hospital

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: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1)Aged 18 to 65 years old,no gender limitation;
(2)Consistent with the clinical diagnosis of influenza;
(3)Patients whose rapid influenza diagnostic tests result are positive;
(4)Patients who accord with the dialectical standard of exogenous wind-heat syndrome in traditional Chinese medicine;
(5)The axillary temperature 38 ? or higher;
(6)Course within 48 hours(Definition of onset time of disease:fever with other typical flu symptoms,for instance headache,myalgia,chilly,shiver,joint pain,weak,pharyngalgia,cough,nasal congestion,runny nose,etc.at least one of the above);
(7)Sign the informed consent before the test,and have a good understanding of the test contents, process and possible adverse reactions.

Exclusion Criteria

(1)Allergic constitution or allergic to known components of the test drug or control drug;
(2)Patients who accord with the diagnostic criteria of Severe and critically ill cases in Influenza Diagnosis and Treatment Protocol (2020 Edition) published by National Health Commission;
(3)The occurrence of other serious clinical conditions requiring monitoring treatment;
(4)Patients with acute bacterial sinusitis,anaphylactic rhinitis,tracheitis - bronchitis,pneumonia,herpangina,etc.;
(5)Patients with serious primary diseases of cardiovascular,cerebrovascular,lung,kidney and hematopoietic system;
(6)Patients with acute or chronic gastroenteritis and unexplained diarrhea 1 week before administration;
(7)Liver function test values (ALT, AST) were 1.5 times higher than the upper limit of normal values;Serum creatinine exceeds the upper limit of normal;
(8)Blood leukocyte <3.0×10^9/L or >10.0×10^9/L;and/or neutrophils above the upper limit of normal values,consider bacterial infection;
(9)Patients who have taken other medications for the disease within 24 hours prior to administration(Including antiviral, hormone and other Chinese and western drugs and treatment methods);
(10)Suspected or present history of alcohol or drug abuse;
(11)Pregnancy,preparing for pregnancy or lactating women,patients who are in reproductive age unable or unwilling take adequate contraceptive measures or their spouse's reluctance to use contraception;
(12)Patients with mental disorders who are unable to cooperate;
(13)Participated in other interventional clinical trials within the last 3 months;
(14)Patients deemed unsuitable by the investigator to participate in this clinical trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Time to remission of clinical symptoms of influenza;

Secondary Outcome Measures

Name	Time	Method
Disease recovery time/recovery rate;TCM syndrome efficacy;Complication,severe illness,critical illness incidence;Antifebrile effect time/Completely antifebrile time;The frequency and the dosage of emergency medicine;Negative rate of virus;