A Registry Study of Shujinjianyao Pill Used in Clinical Real World

Study Overview
=================
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.

Official Title
-----------------
A Registry Study of Shujinjianyao Pill Used in Clinical Real World

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Drug: Shujinjianyao Pill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Patients with normal liver function before medication. 2.Patients suffered from Waist and knee pain or sciatica. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Shujinjianyao Pill|According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） 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. | After using Shujinjianyao Pill about four weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is there any abnormality in renal function test index（Bun、Cr） after medication? | 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. | After using Shujinjianyao Pill around four weeks. | 
| Is there any abnormality in electrocardiogram after medication? | 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. | After using Shujinjianyao Pill around four weeks. | 
| Is there any abnormality in blood routine examination after medication? | Blood routine examination is a commonly used index for observing the therapeutic effect and guiding medication and treatment. | After using Shujinjianyao Pill around four weeks. | 
| Is there any abnormality in routine urinalysis after medication? | 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. | After using Shujinjianyao Pill around four weeks. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Waist and knee pain, sciatica