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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03060252
Other study ID # 302-xxh-ZGGJP
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 15, 2017
Last updated March 25, 2017
Start date March 25, 2017
Est. completion date December 31, 2017

Study information

Verified date March 2017
Source Beijing 302 Hospital
Contact Xiao-he Xiao
Phone +86 66933322
Email pharmacy302xxh@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This is a prospective registry study to surveil early liver injuries caused by Zhuanggu Guanjie Pill (ZGGJ Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.


Description:

The primary objectives of this study include:

(i) The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to ZGGJ Pill.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Individuals in accordance with indications for ZGGJ Pill, including osteoarthritis, and lumbar muscle strain;

2. The age range of 18 to 70 years;

3. Individuals taking ZGGJ Pill over 2 weeks;

4. Abnormalities of serum biochemistry achieving one of the criteria as follows:

(i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) =2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) = 2 ULN; (iii) alkaline phosphatase (ALP) = 2 ULN;

5. Individuals can provide informed consent form.

Exclusion Criteria:

1. Individuals without indications for ZGGJ Pill;

2. Inconformity with the ZGGJ Pill drug label;

3. Individual taking ZGGJ Pill within 2 weeks;

4. Individuals taking other hepatotoxic drugs combined with ZGGJ Pill, simultaneously;

5. Inconformity with the diagnostic criteria for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China 302 Military Hospital Beijing Shi Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Disease progression of HILI caused by ZGGJ Pill, i.e. death, liver failure, chronic DILI, recovery. Disease progression of HILI caused by ZGGJ Pill, i.e. death, liver failure, chronic DILI, recovery. 8 weeks
Primary The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill. The detection of patients with serum liver biochemistry abnormalities less than 8 weeks after intake of ZGGJ Pill. participants will be followed duration intake of ZGGJ Pill, an expected average within 8 weeks
Secondary Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function. Clinical features of early liver injuries caused by ZGGJ Pill assessed by serum parameters of liver function. Participants will be followed duration intake of ZGGJ Pill, an expected average of 8 weeks
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