NCT02559960

Brief Summary

This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
20,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

15 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

5.9 years

First QC Date

September 24, 2015

Last Update Submit

April 6, 2021

Conditions

Adverse Drug EventAdverse Drug ReactionChinese MedicineAnaphylactic Reaction

Outcome Measures

Primary Outcomes (1)

  • The incidence of anaphylactic reaction to Breviscapine Powder-Injection

    1 years

Secondary Outcomes (6)

  • The incidence of severe adverse events (SAEs) to Breviscapine Powder-Injection

    1 years

  • The incidence of new SAEs to Breviscapine Powder-Injection

    1 years

  • The incidence of adverse drug events (ADEs) to Breviscapine Powder-Injection

    1 years

  • The incidence of new ADEs to Breviscapine Powder-Injection

    1 years

  • The effective rate of Breviscapine Powder-Injection

    1 years

  • +1 more secondary outcomes

Study Arms (1)

Breviscapine Powder-Injection

Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc.

Drug: Breviscapine Powder-Injection

Interventions

Breviscapine Powder-InjectionDRUG

Patients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.

Also known as: Zhusheyong Deng-zhan-hua-su
Breviscapine Powder-Injection

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

You may qualify if:

  • Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

The People's Hospital of Zuanjiang District, Chongqing City

Chongqing, Chongqing Municipality, 401420, China

Location

Mudanjiang City Second People's Hospital

Mudanjiang, Heilongjiang, 157013, China

Location

People's Hospital of Jun County

Hebi, Henan, 456250, China

Location

People's Hospital of Changge City

Xuchang, Henan, 461599, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

Zhengzhou Second Hospital

Zhengzhou, Henan, 450015, China

Location

The First Hospital of Henan College of Traditional Chinese Medicine

Zhengzhou, Henan, 451199, China

Location

Zaozhuang Hospital of T.C.M

Zaozhuang, Shandong, 277000, China

Location

Shandong Energy Zaozhuang Mining Group Center Hospital

Zaozhuang, Shandong, 277800, China

Location

Shanxi Provincial Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, 030012, China

Location

Changzheng Hospital of Tianjin City

Tianjin, Tianjin Municipality, 300021, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The Red Cross Hosptal of Yunnan

Kunming, Yunnan, 650021, China

Location

First Affilicated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse ReactionsAnaphylaxis

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Zhong Wang, M.D.

    China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

  • Xin-zhi Wang

    The First Hospital of Henan College of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 25, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2021

Study Completion

December 1, 2021

Last Updated

April 8, 2021

Record last verified: 2021-04

Locations

CN(15)