A Registry Study of Shujinjianyao Pill Used in Clinical Real World

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Sciatica

Treatments: Drug: Shujinjianyao Pill

Study type: Observational

Funder types: Other

Identifiers

NCT03598153

Shujin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.