Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World

• Conditions: Respiratory Infectious Diseases

• Registration Number: NCT04031651
• Lead Sponsor: China Academy of Chinese Medical Sciences

Brief Summary

To obtain the characteristics of adverse reactions/incidents, analyze the influencing factors and calculate the incidence of adverse reactions/incidents monitored by Pudilan Xiaoyan Oral Liquid in key specialties in the real world, so as to provide a basis for clinical safe and rational drug use.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-07-12
• Study Start: 2019-07-17
• Primary Completion: 2019-07-17
• Study First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Study First Posted: 2019-07-24
• Last Update Posted: 2019-07-24
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
• (2)Aged between 18 and 80.

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Exclusion Criteria

• Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Drug Reaction	7 days	Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction

Secondary Outcome Measures

Name	Time	Method
The Ratio of Body Temperature to Normal	7 days	The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)
Change of liver function	7 days	Observation of liver function in at least 3000 patients before and after medication.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase.To observe whether the above liver function indexes appear abnormal once after medication.
Change of renal function	7 days	Observation of renal function in at least 3000 patients before and after medication.The renal function includes creatinine,usea nitrogen.To observe whether the above renal function indexes appear abnormal once after medication.