NCT01764204

Brief Summary

To highlight the incidence of adverse reactions of Qingkailing Injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30,840

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

48 active sites

Status
completed

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

January 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 9, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

4.9 years

First QC Date

January 7, 2013

Last Update Submit

February 15, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence of severe adverse drug reactions

    2 years

Secondary Outcomes (1)

  • incidence of adverse drug reactions

    2 years

Study Arms (1)

Qingkailing Injection

Drug: Qingkailing Injection

Interventions

Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.

Also known as: Shineway Qingkailing Injection
Qingkailing Injection

Eligibility Criteria

Age1 Year - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.

You may qualify if:

  • all the patients treated by Qingkailing Injection in the certain centers(hospitals) in the next 2 years.
  • in accordance with ethics requirements.

You may not qualify if:

  • none.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

National Defense University Hospital of People's Liberation Army

Beijing, Beijing Municipality, 100094, China

Location

Ren'ai Hospital

Shenzhen, Guangdong, 518000, China

Location

Chinese Medicine Hospital of Deqing County

Zhaoqing, Guangdong, 526600, China

Location

Chinese Medicine Hospital of Gaoyang County

Baoding, Hebei, 071599, China

Location

Gaoyang County Hospital

Baoding, Hebei, 071599, China

Location

The Third People's Hospital of Xiong County

Baoding, Hebei, 071802, China

Location

Chinese Medicine Hospital of Xiong County

Baoding, Hebei, 071899, China

Location

Chinese Medicine Hospital of Tang County

Baoding, Hebei, 072350, China

Location

People's Hospital of Tang County

Baoding, Hebei, 072350, China

Location

Chinese Medicine Hospital of Handan City

Handan, Hebei, 056001, China

Location

The First Hospital of Yongnian District

Handan, Hebei, 057150, China

Location

The Second Hospital of Yongnian District

Handan, Hebei, 057150, China

Location

Central Hospital of Shijiazhuang City

Shijiazhuang, Hebei, 050011, China

Location

Hebei Chest Hospital

Shijiazhuang, Hebei, 050041, China

Location

Chinese Medicine Hospital of Shijiazhuang City

Shijiazhuang, Hebei, 050061, China

Location

Central Hospital of Qinghe County

Xingtai, Hebei, 054000, China

Location

Chinese Medicine Hospital of Xingtai City

Xingtai, Hebei, 054001, China

Location

Eye Hospital of Xingtai City

Xingtai, Hebei, 054001, China

Location

The Second Affiliated Hospital of Xingtai Medical College

Xingtai, Hebei, 054099, China

Location

Chinese Medicine Hospital of Qinghe County

Xingtai, Hebei, 054800, China

Location

The Second Hospital of Bayan County

Harbin, Heilongjiang, 151801, China

Location

Luohe Hospital of Chinese Medicine

Luohe, Henan, 462099, China

Location

Central Hospital of Sanmenxia City

Sanmenxia, Henan, 472000, China

Location

People's Hospital of Shan County

Sanmenxia, Henan, 472100, China

Location

The First People's Hospital of Lingbao

Sanmenxia, Henan, 472500, China

Location

Chinese Medicine Hospital of Xinxiang City

Xinxiang, Henan, 453003, China

Location

The Third Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453003, China

Location

People's Hospital of Yanjin County

Xinxiang, Henan, 453200, China

Location

Chinese Medicine Hospital of Fengqiu County

Xinxiang, Henan, 453300, China

Location

People's Hospital of Fengqiu County

Xinxiang, Henan, 453399, China

Location

People's Hospital of Yuanyang County

Xinxiang, Henan, 453500, China

Location

People's Hospital of Xinzheng City

Xinzheng, Henan, 451100, China

Location

Third Affiliated Hospital of Henan College of Traditional Chinese Medicine

Zhengzhou, Henan, 450008, China

Location

Chinese Medicine Hospital of Xinzheng

Zhengzhou, Henan, 451199, China

Location

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

Location

Central Hospital of Liaocheng City

Liaocheng, Shandong, 252001, China

Location

Veterans'Hospital

Liaocheng, Shandong, 252003, China

Location

Chinese Medicine Hospital of Dongchangfu District

Liaocheng, Shandong, 252027, China

Location

Chinese Medicine Hospital of Chiping County

Liaocheng, Shandong, 252100, China

Location

YangGuXian People's Hospital

Liaocheng, Shandong, 252300, China

Location

Chinese Medicine Hospital of Linqing

Liaocheng, Shandong, 252661, China

Location

Chinese Medicine Hospital of Gaotang County

Liaocheng, Shandong, 252800, China

Location

Community Health Center of Duqiao

Weinan, Shanxi, China

Location

Chinese Medicine Hospital of Sanyuan County

Xianyang, Shanxi, 713800, China

Location

People's Hospital of Fuyuan County

Qujing, Yunnan, 655500, China

Location

Chinese Medicine Hospital of Luliang County

Qujing, Yunnan, 655600, China

Location

People's Hospital of Luliang County

Qujing, Yunnan, 655600, China

Location

Chinse Medical Hospital of Shizong County

Qujing, Yunnan, 655700, China

Location

Related Publications (1)

  • Yao Q, Wei T, Qiu H, Cai Y, Yuan L, Liu X, Li X. Epigenetic Effects of Natural Products in Inflammatory Diseases: Recent Findings. Phytother Res. 2025 Jan;39(1):90-137. doi: 10.1002/ptr.8364. Epub 2024 Nov 8.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood of the patient with severe adverse drug reactions

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Qingkailing

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Zhong Wang, Ph.D., M.D.

    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
Professor

Study Record Dates

First Submitted

January 7, 2013

First Posted

January 9, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations