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

Respiratory Infectious Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04031651
• Other study ID #: PUDILAN
• Status: Not yet recruiting
• Start date: July 17, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2019
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: datamining5288[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2021
• Est. primary completion date: July 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Infectious Diseases

Intervention

Drug:
• Pudilan Xiaoyan Oral Liquid
In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Xiyuan Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The Ratio of Body Temperature to Normal	The Ratio of Body Temperature to Normal(Lower Than 37.3ºC)	7 days
Secondary	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
Secondary	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