MedDataX Logo

A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World

NCT ID: NCT03192787

Last Updated: 2017-06-20

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is get to know what and how Sanwujiaowan capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Registration of Xinyuan Capsule

NCT03197844

Coronary Disease
UNKNOWN

Pharmacokinetics, Safety, and Tolerability of Various XW10172 Oral Formulations in Healthy Adult Volunteers

NCT04688580

Healthy
COMPLETED EARLY_PHASE1

An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

NCT04631549

Hepatic Impairment Healthy Participants
UNKNOWN PHASE1

Pharmacokinetic Study of Oligonucleotides in Maixuekang Capsules

NCT06823895

Healthy
RECRUITING PHASE1

A Phase 1 Study of SSS17 in Healthy Subjects.

NCT04893187

Anemia in Chronic Kidney Diseases
UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in hospital, registry study is suitable method in this area. Otherwise, nested case control study is used to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or adverse drug reactions is one of the main aims for this study. Safety surveillance on Chinese medicine containing Radix Polygoni Multiflori is an important problem that needs to be sorted out through large sample observational study. According to the relevant regulations of the CFDA, 3000 cases need to be registered at least. The aim population is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatism Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.

Exclusion Criteria

NONE
Minimum Eligible Age

1 Hour

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Yanming Xie

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yanming Xie

Deputy Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yanming Xie, BA

Role: PRINCIPAL_INVESTIGATOR

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

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yanming Xie, BA

Role: CONTACT

[email protected]
86-13911112416

Lianxin Wang, doctor

Role: CONTACT

[email protected]
86-13521781839

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Sanwujiaowan

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pharmacokinetics and Metabolism Study of Radiolabeled BMS-986142 in Healthy Male Subjects
NCT02880670 COMPLETED PHASE1
Pharmacokinetics and Safety/Tolerability After Oral Administration of CKD-387 and D484 in Healthy Adults
NCT03646799 UNKNOWN PHASE1
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.
NCT03091556 UNKNOWN
Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
NCT02291471 COMPLETED PHASE1
Relative Bioavailability Study of SHR3680
NCT04903158 UNKNOWN PHASE1
A Randomized,Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of MT2004 Capsule in DILI Subjects
NCT06019936 UNKNOWN PHASE2
A Phase 1 Clinical Trial of NTQ5082 in Healthy Volunteers
NCT06560593 NOT_YET_RECRUITING PHASE1
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
NCT02004587 COMPLETED PHASE1
Pharmacokinetics and Pharmacodynamics Study of Alogliptin in Healthy Korean Participants
NCT01391663 COMPLETED PHASE1
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Escalating Single and Multiple Doses of KP104
NCT05490017 COMPLETED PHASE1
Pharmacokinetics of ZSP1273 in Participants With Hepatic Impairment
NCT05856513 COMPLETED PHASE1
A Study to Evaluate the Pharmacokinetics and Safety of INCB054707 in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
NCT05624710 COMPLETED PHASE1
Single-dose Pharmacokinetics of BMS-986177 in Participants With Hepatic Impairment Compared to Healthy Participants
NCT02982707 COMPLETED PHASE1
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment
NCT03160014 UNKNOWN PHASE1
Relative Bioavailability and Effect of Food Study With AGMB-129 in Healthy Participants
NCT06397508 COMPLETED PHASE1
Post-market Safety Reassessment of Ulinastatin for Injection
NCT02520570 UNKNOWN
Ulonivirine (MK-8507) in Participants With Mild or Moderate Hepatic Impairment (MK-8507-014)
NCT05093972 NOT_YET_RECRUITING PHASE1
An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants
NCT04631575 UNKNOWN PHASE1
A Study to Evaluate the Pharmacokinetics and Safety of Diluted vs. Undiluted Intravenous DA-5217 in Healthy Adult Subjects
NCT07027982 COMPLETED PHASE1
Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949
NCT02099071 COMPLETED PHASE1
A Retrospective Study on Drug Induced Liver Injury in China
NCT02407964 COMPLETED
Study to Assess Pharmacokinetics, Safety, and Tolerability of MT-7117 in Subjects With Normal and Impaired Hepatic Function
NCT04116476 COMPLETED PHASE1
Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject
NCT05684653 UNKNOWN PHASE1
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
NCT05868967 UNKNOWN PHASE1
A Study Evaluating the Food Effect on the Pharmacokinetics of SSS17 Capsules in Chinese Healthy Subjects
NCT07024888 COMPLETED PHASE1