A Registry Study of Shujinjianyao Pill Used in Clinical Real World

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.

Study Overview

• Status: Unknown
• Conditions: Sciatica
• Intervention / Treatment: Drug: Shujinjianyao Pill

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

With normal liver function before medication, patients suffered from waist and knee pain or sciatica.

Description

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.

Study Plan

How is the study designed?

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.

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Wangjing Hospital, China Academy of Chinese Medical Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 25, 2018
• Primary Completion (Anticipated): October 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: July 14, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: sciatica; Waist and knee pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuralgia; Sciatica
• Other Study ID Numbers: Shujin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No