A Registry Study on Xiyanping(a Chinese Medicine Injection) Used in Fifty Hospitals

NCT01612572 | Unknown DMC

• 2 other identifiers: RSCMI-ⅢRSCMI- Ⅲ
• Study Type: observational
• Target: 20,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was advocated by Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences in October 2011. It was funded by China major scientific and technological specialized project for 'significant new formulation of new drugs'. Xiyanping is kind of Chinese Medicine injection used for treating viral pneumonia 、bronchitis、amygdalitis、infantile diarrhea、bacillary dysentery 、virus hepatitis、and Children acute hot diseases in many Chinese hospitals. The purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 20,000 patients.

Conditions

Viral Pneumonia; Bronchitis; Infantile Diarrhea; Bacillary Dysentery; Virus Hepatitis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events; incidence of Xiyanping'ADRs and identify factors that contributed to the occurrence of the adverse reaction

  The registry procedure will last 3 years only for patients using Xiyanping.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An anticipated sample size was caculated in this study, about 20000. Patients using Xiyanping injection from 2012 to 2014 in more than 50 hospitals

You may qualify if:

• Xiyanping injection from 2012 to 2014

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead

MeSH Terms

Conditions

Pneumonia, Viral; Bronchitis; Diarrhea, Infantile; Dysentery, Bacillary

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Diarrhea; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Dysentery; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Yan M Xie, BA

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

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: June 3, 2012
• First Posted: June 6, 2012
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 6, 2012

Record last verified: 2012-06