SciaticaNCT03598153
A Registry Study of Shujinjianyao Pill Used in Clinical Real World
An observational study of Sciatica, run by China Academy of Chinese Medical Sciences.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sciatica
- What is being tested?
- Shujinjianyao Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2018to 31 Dec 2019
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: With normal liver function before medication, patients suffered from waist and knee pain or sciatica.
Who may be able to join
- 1.Patients with normal liver function before medication.
- 2.Patients suffered from Waist and knee pain or sciatica.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Sciatica
- Being tested
- Shujinjianyao Pill
- Keywords
- Waist and knee pain, sciatica
- Medical subject headings
- Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shujinjianyao PillDrug
According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After using Shujinjianyao Pill about four weeks.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After using Shujinjianyao Pill around four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start25 Jul 2018 (estimated)
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SciaticaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Responsible party
- Principal investigator, Yanming Xie, China Academy of Chinese Medical Sciences
- Investigators
- Yanming Xie, BA, Principal investigator, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598153
- Sponsor's protocol ID
- Shujin
- Status last verified
- Jun 2018
- First submitted
- 24 Jun 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31415416
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry Study of Shujinjianyao Pill Used in Clinical Real World
- ClinicalTrials.gov ID
- NCT03598153
- Acronym / sponsor ID
- Shujin
- Conditions
- Sciatica
- Keywords
- Waist and knee pain, sciatica
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Study start
- 25 Jul 2018 (estimated)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- With normal liver function before medication, patients suffered from waist and knee pain or sciatica.
Key inclusion criteria (2 listed)
- 1.Patients with normal liver function before medication.
- 2.Patients suffered from Waist and knee pain or sciatica.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shujinjianyao PillAccording to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks. | Drug | – |
Primary outcome
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using Shujinjianyao Pill about four weeks ?
Time frame: 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.
4 secondary outcomes
Is there any abnormality in renal function test index（Bun、Cr） after medication?
Time frame: After using Shujinjianyao Pill around four weeks.
Is there any abnormality in electrocardiogram after medication?
Time frame: After using Shujinjianyao Pill around four weeks.
Is there any abnormality in blood routine examination after medication?
Time frame: After using Shujinjianyao Pill around four weeks.
Is there any abnormality in routine urinalysis after medication?
Time frame: After using Shujinjianyao Pill around four weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Derived from this study: PubMed 31415416Cui 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.
- Individual participant dataSharing planned: No
Related trials for Sciatica
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
RecruitingPhase 1
Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Lumbosacral Radicular Pain, Sciatic Radiculopathy
Recruiting
Effect of Sensorimotor Training on Pain and Gait Performance in Patients With Discogenic Sciatica
Sciatica Due to Intervertebral Disc Disorder
Not yet recruiting
Randomized Evaluation of Lumbar Injection Effectiveness and Function
Lumbar Radiculopathy, Lumbar Disc Herniation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanming Xie, BA principal investigator
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica, run by China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanming Xie, BA (86-13911112416, ktzu2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Is there any abnormality in liver function test index（ALT、AST、TBil、GGT） after using Shujinjianyao Pill about four weeks ? (time frame: After using Shujinjianyao Pill about four weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03598153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.