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

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Infectious Diseases
• Intervention / Treatment: Drug: Pudilan Xiaoyan Oral Liquid

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Drug Reaction	Incidence of Reduning Injection'Adverse Drug Reaction（ADRs）and Identify Factors That Contributed to the Occurrence of the Adverse Drug Reaction	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Ratio of Body Temperature to Normal	The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)	7 days
Change of liver function	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.	7 days
Change of renal function	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.	7 days

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Xiyuan Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Yanming Xie, BA, Institute of Basic Research in Clinical Medicine, China Academy of Chinese

Study record dates

Study Major Dates

• Study Start (Anticipated): July 17, 2019
• Primary Completion (Anticipated): July 17, 2019
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pudilan Xiaoyan Oral Liquid; Safety monitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: PUDILAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No