A Registry Study of Shujinjianyao Pill Used in Clinical Real World
- Conditions
- Sciatica
- Registration Number
- NCT03598153
- Lead Sponsor
- China Academy of Chinese Medical Sciences
- Brief Summary
The purpose of this study is to get to know how Shujinjianyao Pill in hospital results in drug-induced liver injury or other adverse drug reactions from a cohort event monitoring as registration research.
- Detailed Description
In order to monitor drug-induced liver injury or other adverse drug reactions of Shujinjianyao Pill in clinical real world, registry study is a suitable method in this area. Meanwhile, the investigators will use nested case-control study to find out the mechanism of drug-induced liver injury. Calculate the incidence of drug-induced liver injury or other adverse drug reactions is one of the main aims for this study. Therefore, Safety monitoring of Shujinjianyao Pill is an very important problem that needs to be done through a large sample observational study. According to the relevant regulations of the state drug administration(SDA), 3000 cases need to be registered at least. The aim population is who use Shujinjianyao Pill with normal liver function before medication from June 2018 to October 2019.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- 1.Patients with normal liver function before medication.
- 2.Patients suffered from Waist and knee pain or sciatica.
- 1.Patients who are pregnant, phrenetic, and suffered from serious illness.
- 2.Patients suffered from viral hepatitis or autoimmune hepatitis or alcoholic hepatitis or hereditary metabolic hepatitis or cirrhosis or cancer of the liver.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using Shujinjianyao Pill about four weeks ? After using Shujinjianyao Pill about four weeks. The liver function test index mainly includes glutamic-pyruvic transaminase(ALT),glutamic-oxalacetic transaminase(AST), gamma-glutamyl transpeptidase(GGT) and total bilirubin(TBil). If the index is abnormal, it indicates abnormal liver function, and severe cases can lead to liver injury.
- Secondary Outcome Measures
Name Time Method Is there any abnormality in blood routine examination after medication? After using Shujinjianyao Pill around four weeks. Blood routine examination is a commonly used index for observing the therapeutic effect and guiding medication and treatment.
Is there any abnormality in electrocardiogram after medication? After using Shujinjianyao Pill around four weeks. Electrocardiogram is a special device that amplifies the electrical effects of heart contractions and diastasis by drawing wavy stripes on paper.The observation of electrocardiogram can help diagnose various heart diseases.If someone has an electrocardiogram, doctors use special equipment to measure the electric currents produced by that person's heart in order to see whether it is working normally.
We want to monitor whether medication is harmful to electrocardiogram.Is there any abnormality in renal function test index（Bun、Cr） after medication? After using Shujinjianyao Pill around four weeks. The renal function test index mainly includes creatinine(Cr) and urea nitrogen (Bun).
If the index is abnormal, it indicates abnormal kidney function. We plan to monitor whether medication is harmful to renal function test index.Is there any abnormality in routine urinalysis after medication? After using Shujinjianyao Pill around four weeks. As an indicator of excretion, routine urinalysis reflects the body's metabolic state and is an important indicator of many diseases.
We want to monitor whether medication is harmful to routine urinalysis.