A Registry Study of Shujinjianyao Pill Used in Clinical Real World

Sciatica Clinical Trial

Official title:

A Registry Study of Shujinjianyao Pill Used in Clinical Real World

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03598153
• Other study ID #: Shujin
• Status: Not yet recruiting
• Start date: July 25, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2018
• Source: China Academy of Chinese Medical Sciences
• Contact: Yanming Xie, BA
• Phone: 86-13911112416
• Email: ktzu2018[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sciatica

Intervention

Drug:
• Shujinjianyao Pill
According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Wangjing Hospital, China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.