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A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World

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ClinicalTrials.gov Identifier: NCT03192748
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:
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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 Runzaozhiyang capsule in hospital results in drug-induced liver injury or adverse drug reactions from a cohort event monitoring as registration research.

Condition or disease
Eczema

Detailed Description:
In order to improving monitoring drug-induced liver injury or adverse drug reactions of Chinese medicine containing Radix Polygoni Multiflori in clinical real world, 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 Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Registry Study of Runzaozhiyang Capsule Used in Clinical Real World
Estimated Study Start Date : June 19, 2017
Estimated Primary Completion Date : June 19, 2017
Estimated Study Completion Date : June 30, 2019

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 runzaozhiyang capsule around two weeks later? [ Time Frame: After using runzaozhiyang capsule around two 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 medication? [ Time Frame: After using runzaozhiyang capsule around two 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 medication? [ Time Frame: After using runzaozhiyang capsule around two 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)? [ Time Frame: During using runzaozhiyang capsule around two 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.



Information from the National Library of Medicine

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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 Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.
Criteria

Inclusion Criteria:

Patients using Runzaozhiyang capsule 's with abnormal liver function before medication from June 2017 to June 2019.

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): NCT03192748


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
China Academy of Chinese Medical Sciences
Xiyuan Hospital of China Academy of Chinese Medical Sciences
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: NCT03192748     History of Changes
Other Study ID Numbers: Runzao
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