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A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World

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ClinicalTrials.gov Identifier: NCT03192787
Recruitment Status : Unknown
Verified June 2017 by Yanming Xie, China Academy of Chinese Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Collaborator:
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Yanming Xie, China Academy of Chinese Medical Sciences

Brief Summary:
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.

Condition or disease
Rheumatism Osteoarthritis

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study of Sanwujiaowan Capsule Used in Clinical Real World
Estimated Study Start Date : June 19, 2017
Estimated Primary Completion Date : June 19, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Is there any abnormality in liver function test index(ALT、AST、TBil、GGT) after using sanwujiaowan capsule around four weeks later? [ Time Frame: After using sanwujiaowan capsule around four weeks later ]
    Based on data from the National Center for adverse drug reactions (ADR), Chinese herbal medicine containing Polygonum multiflorum may cause liver damage, but further confirmation is needed.The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase,GGT,TBil.


Secondary Outcome Measures :
  1. Is there any abnormality in renal function test index(Bun、Cr) after using sanwujiaowan capsule around four weeks later? [ Time Frame: After using sanwujiaowan capsule around four weeks later. ]
    Observation of whether the kidney function damage after treatment.The renal function includes creatinine,usea nitrogen.

  2. Is there any abnormality in ECG after using sanwujiaowan capsule around four weeks later? [ Time Frame: After using sanwujiaowan capsule around four weeks later. ]
    Observation of whether the ECG damage after treatment.ECG is the most common method of detection of myocardial ischemia and the diagnosis of angina pectoris.

  3. Is there any abnormality in basic life sign(body temperature, blood pressure and pulse)during using sanwujiaowan capsule around four weeks? [ Time Frame: During using sanwujiaowan capsule around four weeks. ]
    Observation of whether the basic life sign damage after treatment.In the medical care system, body temperature, blood pressure and pulse are the most important and basic three physiological parameters of the vital signs.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The aim population for observation is who using Sanwujiaowan capsule 's with abnormal liver function before medication from June 2017 to December 2018.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

NONE


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192787


Contacts
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Contact: Yanming Xie, BA 86-13911112416 datamining5288@163.com
Contact: Lianxin Wang, doctor 86-13521781839 wanglianxin_tcm@126.com

Sponsors and Collaborators
Yanming Xie
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Yanming Xie, BA Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Yanming Xie, Deputy Director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03192787     History of Changes
Other Study ID Numbers: Sanwujiaowan
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Osteoarthritis
Rheumatic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases