Clinical trial NCT03598153: A Registry Study of Shujinjianyao Pill Used in Clinical Real World
Official title: A Registry Study of Shujinjianyao Pill Used in Clinical Real World
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sciatica
Keywords: Waist and knee pain
sciatica
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Wangjing Hospital, China Academy of Chinese Medical Sciences
First posted: 2018-07-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: With normal liver function before medication, patients suffered from waist and knee pain or sciatica.

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.

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.

Primary outcomes:
measure: Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using Shujinjianyao Pill about four weeks ?
timeFrame: After using Shujinjianyao Pill about four weeks.
Secondary outcomes:
measure: Is there any abnormality in renal function test index（Bun、Cr） after medication?
timeFrame: After using Shujinjianyao Pill around four weeks.
measure: Is there any abnormality in electrocardiogram after medication?
timeFrame: After using Shujinjianyao Pill around four weeks.
measure: Is there any abnormality in blood routine examination after medication?
timeFrame: After using Shujinjianyao Pill around four weeks.
measure: Is there any abnormality in routine urinalysis after medication?
timeFrame: After using Shujinjianyao Pill around four weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cui X, Liang L, Wang L, Wang Z, Li Y, Gao Y, Zhang C, Sun M, Wang S, Liu J, Zhang Y, Wang Z, Wei X, Xie Y. Safety of Shujinjianyao pill in clinical real world: A prospective, observational, multicenter, large-sample study Protocol. Medicine (Baltimore). 2019 Aug;98(33):e16853. doi: 10.1097/MD.0000000000016853.