Chai-Yin particles in the treatment of mild flu randomized, double-blind, positive drug parallel control study

Phase 1

Recruiting

• Conditions: Mild flu

• Registration Number: ITMCTR2000003925
• Lead Sponsor: Beijing 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) course of 36 hours or less;
(2) temperature is 37.5 degrees C or higher with flu-like symptoms and has a history of epidemiology;
(3) test positive for influenza virus antigen;
(4) the age of 18 years old or more, < 65 years old;
(5) in the diagnosis and treatment scheme (2019) influenza mild of traditional Chinese medicine dialectical;
(6) agreed to sign a consent form.

Exclusion Criteria

(1) Mental illness, or other cooperation or not let collaborators.
(2) for nearly three months to participate in other subjects.
(3) the researcher has the following flu complications in patients with known risk factors:
A) pregnancy women or puerperal women;
B) chronic respiratory diseases, including COPD and asthma;
C) the nervous system diseases and neurodevelopmental disorders, including brain, spinal cord, peripheral nerve and muscle disease (for example, cerebral palsy, epilepsy seizure, stroke, mental retardation, moderate to severe retardation, muscular dystrophy or spinal cord injury (sci).
D) heart disease, for example, congenital heart disease, congestive heart failure, or coronary artery disease), not including any other heart related symptoms of high blood pressure;
E) blood system diseases;
F) the endocrine system diseases (not including glycosylated hemoglobin < 8%;
G) kidney disease: creatinine clearance 60 mL/min or less;
H) of the liver disease including hepatitis, liver cirrhosis, moderately severe fatty liver, not including the AST and ALT rise less than the upper limit of normal 50 % asymptomatic liver function is unusual).
I) metabolic disorders (protein metabolism disorder, sugar metabolic disorder, lipid metabolism disorders, water, electrolyte metabolic disorders, high blood uric acid);
J) immune system damage (including patients with immunosuppressive therapy, or cancer or patients with human immunodeficiency virus (HIV) infection);
K) in patients with obesity (body mass index (BMI) of 30 or more).
(4) the index case weight < 40 kg;
(5) has a history of alcohol or drug abuse.
(6) within 30 days before the screening, have received the following medications: Baloxavir, palmer peramivir, pull nimmi wei, oseltamivir and zanamivir, rimantadine, Abby dole, amantadine hydrochloride or experimental drugs;
(7) 12 months to receive influenza vaccination;
(8) into groups of 6 h used antipyretic analgesic drugs;
(9) into the group of 12 h application anti-flu features of proprietary Chinese medicine.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
A completely antifebrile time;24h, 48h rate of fever;Antifebrile effect time;