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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04031651

Enrollment

10000

Registered

2019-07-24

Start date

2019-07-17

Completion date

2021-12-31

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infectious Diseases

Keywords

Pudilan Xiaoyan Oral Liquid, Safety monitoring

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.

Interventions

DRUGPudilan 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Contacts

Primary ContactYanming Xie, BA

datamining5288@163.com86-13911112416

Backup ContactQing Miao, doctor

wlxing@126.com86-13910812309

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026