A Registry Study of Shujinjianyao Pill Used in Clinical Real World

NCT03598153 | Unknown DMC

• 1 other identifier: Shujin
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sciatica

Keywords

Waist and knee pain; sciatica

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Is there any abnormality in renal function test index（Bun、Cr） after medication?

  After using Shujinjianyao Pill around four weeks.

• Is there any abnormality in electrocardiogram after medication?

  After using Shujinjianyao Pill around four weeks.

• Is there any abnormality in blood routine examination after medication?

  After using Shujinjianyao Pill around four weeks.

• Is there any abnormality in routine urinalysis after medication?

  After using Shujinjianyao Pill around four weeks.

Interventions

Shujinjianyao Pill DRUG

According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with normal liver function before medication.
• Patients suffered from Waist and knee pain or sciatica.

You may not qualify if:

• Patients who are pregnant, phrenetic, and suffered from serious illness.
• Patients suffered from viral hepatitis or autoimmune hepatitis or alcoholic hepatitis or hereditary metabolic hepatitis or cirrhosis or cancer of the liver.

Sponsors & Collaborators

• China Academy of Chinese Medical Sciences: lead
• Wangjing Hospital, China Academy of Chinese Medical Sciences: collaborator

Related Publications (1)

• 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.

  PMID: 31415416 DERIVED

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yanming Xie, BA

  Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanming Xie, BA

CONTACT

86-13911112416; ktzu2018@163.com

Lianxin Wang, Doctor

CONTACT

86-13521781839; wlxing@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: July 26, 2018
• Study Start: July 25, 2018
• Primary Completion: October 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share