Post-marketing Safety Surveillance of Compound Kuh-seng Injection: a Registry Study

NCT ID: NCT02239237

Last Updated: 2018-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30283 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-10-31

Brief Summary

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This registry aims to monitor the safety of Compound Kuh-seng Injection and to identify the potential risk factors for the adverse drug reactions. Compound Kuh-seng Injection is a kind of natural compound injection extracted from herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae.

Detailed Description

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Conditions

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Safety Surveillance Adverse Drug Events Adverse Drug Reactions Severe Adverse Events Severe Adverse Reactions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Compound Kuh-seng Injection

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

Compound Kuh-seng Injection

Intervention Type DRUG

Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine,sophocarpidine, matrine, flavonoid etc.

Interventions

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Compound Kuh-seng Injection

Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine,sophocarpidine, matrine, flavonoid etc.

Intervention Type DRUG

Other Intervention Names

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Compound Kushen Injection Fufang Kushen Zhusheye

Eligibility Criteria

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Inclusion Criteria

* Patients who use Compound Kushen Injection in the monitoring hospitals

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanxi Zhendong pharmaceutical Co. LTD.

UNKNOWN

Sponsor Role collaborator

Zhong Wang

OTHER

Sponsor Role lead

Responsible Party

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Zhong Wang

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Zhong Wang, M.D.

Role: STUDY_DIRECTOR

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

Zhan-Yu Pan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin medical university cancer institute & hosptial

Locations

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HanDan Central Hospital

Handan, Hebei, China

Site Status

Handan First Hospital

Handan, Hebei, China

Site Status

Bai Qiu'en International Peace Hospital

Shijiazhuang, Hebei, China

Site Status

Henan University Huaihe Hospital

Kaifeng, Henan, China

Site Status

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Site Status

Luoyang Central Hospital Affiliated to Zhengzhou University

Luoyang, Henan, China

Site Status

Xinxiang Central Hospital

Xinxiang, Henan, China

Site Status

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status

Xinyang Central Hospital

Xinyang, Henan, China

Site Status

People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

The First Hospital of Henan College of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status

Shandong Provincial Western Hospital

Jinan, Shandong, China

Site Status

Qingdao Center Hospital

Qingdao, Shandong, China

Site Status

Tai'an Central Hospital

Tai’an, Shandong, China

Site Status

The 88th Hospital of People's Liberation Army

Tai’an, Shandong, China

Site Status

People's Hospital of Xintai City

Tai’an, Shandong, China

Site Status

Weifang No.2 People's Hospital

Weifang, Shandong, China

Site Status

Weihai Municipal Hospital

Weihai, Shandong, China

Site Status

Central Hospital of Zibo

Zibo, Shandong, China

Site Status

Jincheng General Hospital

Jincheng, Shanxi, China

Site Status

The Fourth People's Hospital of Linfen

Linfen, Shanxi, China

Site Status

Traditional Chinese Hospital of Shanxi

Taiyuan, Shanxi, China

Site Status

Yuncheng Central Hospital

Yuncheng, Shanxi, China

Site Status

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Site Status

AVIC 363 Hospital

Chengdu, Sichuan, China

Site Status

Teaching Hospital of Chengdu University of T.C.M.

Chengdu, Sichuan, China

Site Status

The Second People's Hospital of Yibin

Yibin, Sichuan, China

Site Status

Tianjin medical university cancer institute & hosptial

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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Kuh-seng1.0

Identifier Type: -

Identifier Source: org_study_id

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