Key Specialized Monitoring of Clinical Safety of Pudilan Xiaoyan Oral Liquid in the Real World
1 other identifier
observational
10,000
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2019
CompletedStudy Start
First participant enrolled
July 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 24, 2019
June 1, 2019
Same day
July 12, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
The Ratio of Body Temperature to Normal
7 days
Change of liver function
7 days
Change of renal function
7 days
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- (1)Upper respiratory tract infection patients using Pudilan antiphlogistic oral liquid ;
- (2)Aged between 18 and 80.
You may not qualify if:
- Lactating women, pregnant women, pregnant planners, psychiatric patients, etc.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wang M, Wang L, Liu F, Chen R, Wang Z, Cui X, Li Y, Xie Y. Clinical Safety of Pudilan Xiaoyan Oral Liquid for the Treatment of Upper Respiratory Tract Infection in the Real World: Protocol for a Prospective, Observational, Registry Study. JMIR Res Protoc. 2025 Mar 21;14:e65789. doi: 10.2196/65789.
PMID: 40117581DERIVED
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Yanming Xie, BA
Institute of Basic Research in Clinical Medicine, China Academy of Chinese
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy Director
Study Record Dates
First Submitted
July 12, 2019
First Posted
July 24, 2019
Study Start
July 17, 2019
Primary Completion
July 17, 2019
Study Completion
December 31, 2021
Last Updated
July 24, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share