Cervical RadiculopathyPhase 4NCT01875562
A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
A Phase 4 study testing Qishe Pill in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Qishe Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- May 2012to Nov 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of chronic neck pain since at least 3 months and complaints for a maximum duration of 5 years.
- average pain intensity of the last 7 days more or equal to 25 points measured by a Neck Disability Index.
- intellectual and physical ability to participate in the study. informed consent.
- One positive result of Brachial Plexus Traction Test, Cervical compression test or Cervical distraction test
Who cannot join
- cervical pain related to malignancy
- cervical pain due to an accident
- inflammatory joint disorders
- previous spine surgery
- protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
- actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
Show all 11Show fewer
- use of pain drugs for other diseases (> 1x/week)
- pregnancy
- severe chronic or acute disease interfering with therapy attendance
- alcohol or substance abuse
- participation in another clinical trial in the last 6 months before study entry
Trial locations and contacts
1 site in 1 country.
Xuejun Cui, Dr contact
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Xuejun Cui, Dr, 13917715524@139.com
Wen Mo, Dr
About this study
Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including Traditional Chinese Medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy.
Read the detailed description
Cervical radiculopathy is a distinct consideration in the evaluation of any patients who have neck pain and may be defined simply as an abnormality of a nerve root which originates in the cervical spine. The initial approach to the management of cervical spondylopathic radiculopathy is nearly the same as that of nonspecific neck or back pain that can be found in most patients. Conservative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), narcotics, muscle relaxants, physical therapy and transcutaneous electrical nerve stimulation (TENS). The main objectives of conservative treatments are to relieve pain, improve function and improve health-related quality of life. However, these treatments for cervical radiculopathy are limited by their modest effectiveness. Surgical treatment for cervical disc disease is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. In terms of pharmacotherapy, there is generally no randomized, placebo-controlled trial available comparing standard nonsurgical treatment. Therefore, care plans should be designed principally based on accumulated experience, the services available locally, and the respective preferences of patients. Treatment plans are developed to alleviate pain, improve function, and prevent recurrences.
As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the adverse effects of medications and surgery.According to the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by pathogenic factors, such as "Feng"(wind), "Han"(cold), "Shi"(dampness), invading the neck induces cervical degenerative disc diseases which are the cause of cervical radiculopathy. According to the four traditional methods of diagnosis -observation, listening, interrogation, and pulse-taking, TCM doctors can analyze the specific pathogenic factors which cause neck pain. Accordingly they can then prescribe herbal formulae based on the effect and the main indications according to the principles of Chinese medicine. Natural substances, including herbal medicines, have been used to promote healing and alleviate neck pain in western countries. Previous studies have demonstrated that some active substances in herbal medicine can promote Qi flow and blood circulation to alleviate pain.
- Conditions
- Cervical Radiculopathy
- Being tested
- Qishe Pill
- Keywords
- Neck pain, Cervical radiculopathy, Qishe Pill, Traditional Chinese Medicine
- Medical subject headings
- Radiculopathy, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qishe PillDrug
Pill, 3.75 g, twice per day, four weeks
| Study group | Role | What they receive |
|---|---|---|
| Qishe Pill | Experimental | Not described Receives: Drug: Qishe Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity(measured with a visual analogue scale, VAS)
Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: changes from baseline at 2 weeks
pain severity(measured with a visual analogue scale, VAS)
Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: changes from baseline at 4 weeks
Secondary outcomes (12)
SF-36
a composite of functional status
Measured: changes from baseline at 2 weeks
Neck Disability Index（NDI）
a composite of functional status
Measured: changes from baseline at 2 weeks
SF-36
a composite of functional status
Measured: changes from baseline at 4 weeks
Neck Disability Index（NDI）
a composite of functional status
Measured: changes from baseline at 4 weeks
Kidney function test
Measured: changes from baseline at 4 weeks
Liver function test
Measured: changes from baseline at 4 weeks
ECG
Measured: changes from baseline at 4 weeks
Occult Blood
Measured: changes from baseline at 4 weeks
Urine routine
Measured: changes from baseline at 4 weeks
Blood routine
Measured: changes from baseline at 4 weeks
Number of participants with Concomitant medication
Measured: 4 weeks
Number of participants with Adverse Events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (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 Cervical RadiculopathyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Huadong Hospital, Shanghai East Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai No.1 Hospital, Shanghai No.6 Hospital, Changhai Hospital
- Responsible party
- Principal investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
- Investigators
- Yongjun Wang, Dr, Principal investigator, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875562
- Sponsor's protocol ID
- PME of Qishe
- Status last verified
- Jun 2013
- First submitted
- 12 Dec 2012
- Last updated
- 12 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cui XJ, Sun YL, Zhang CQ, Wu T, Tan J, Zhu ZA, Chen YQ, Wang QG, Li M, Wang YJ. Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness. Chin J Integr Med. 2021 Jun;27(6):408-416. doi: 10.1007/s11655-021-2868-x. Epub 2021 Apr 21.
PubMed 33881718
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
- ClinicalTrials.gov ID
- NCT01875562
- Acronym / sponsor ID
- PME of Qishe
- Conditions
- Cervical Radiculopathy
- Keywords
- Neck pain, Cervical radiculopathy, Qishe Pill, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Huadong Hospital, Shanghai East Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, Shanghai No.1 Hospital, Shanghai No.6 Hospital, Changhai Hospital
- Study start
- May 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 12 Jun 2013 (estimated)
- 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.
Neck pain is a common symptom in most patients suffering from cervical radiculopathy. However, some conservative treatments are limited by their modest effectiveness. On the other hand, surgical intervention for cervical disc disorders is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. Many patients use complementary and alternative medicine, including Traditional Chinese Medicine, to address their symptoms. The purpose of the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, for neck pain in patients with cervical radiculopathy.
Detailed description
Cervical radiculopathy is a distinct consideration in the evaluation of any patients who have neck pain and may be defined simply as an abnormality of a nerve root which originates in the cervical spine. The initial approach to the management of cervical spondylopathic radiculopathy is nearly the same as that of nonspecific neck or back pain that can be found in most patients. Conservative treatments include non-steroidal anti-inflammatory drugs (NSAIDs), narcotics, muscle relaxants, physical therapy and transcutaneous electrical nerve stimulation (TENS). The main objectives of conservative treatments are to relieve pain, improve function and improve health-related quality of life. However, these treatments for cervical radiculopathy are limited by their modest effectiveness. Surgical treatment for cervical disc disease is indicated when symptoms are refractory to conservative treatments and neurological symptoms are progressive. In terms of pharmacotherapy, there is generally no randomized, placebo-controlled trial available comparing standard nonsurgical treatment. Therefore, care plans should be designed principally based on accumulated experience, the services available locally, and the respective preferences of patients. Treatment plans are developed to alleviate pain, improve function, and prevent recurrences.
As a complementary and alternative medicine (CAM), herbal medicines have the potential to avoid the adverse effects of medications and surgery.According to the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by pathogenic factors, such as "Feng"(wind), "Han"(cold), "Shi"(dampness), invading the neck induces cervical degenerative disc diseases which are the cause of cervical radiculopathy. According to the four traditional methods of diagnosis -observation, listening, interrogation, and pulse-taking, TCM doctors can analyze the specific pathogenic factors which cause neck pain. Accordingly they can then prescribe herbal formulae based on the effect and the main indications according to the principles of Chinese medicine. Natural substances, including herbal medicines, have been used to promote healing and alleviate neck pain in western countries. Previous studies have demonstrated that some active substances in herbal medicine can promote Qi flow and blood circulation to alleviate pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qishe Pill | Experimental | Drug: Qishe Pill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis of chronic neck pain since at least 3 months and complaints for a maximum duration of 5 years.
- average pain intensity of the last 7 days more or equal to 25 points measured by a Neck Disability Index.
- intellectual and physical ability to participate in the study. informed consent.
- One positive result of Brachial Plexus Traction Test, Cervical compression test or Cervical distraction test
Key exclusion criteria (11 listed)
- cervical pain related to malignancy
- cervical pain due to an accident
- inflammatory joint disorders
- previous spine surgery
- protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
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 |
|---|---|---|
| Qishe PillPill, 3.75 g, twice per day, four weeks | Drug | Qishe Pill |
Primary outcome
pain severity(measured with a visual analogue scale, VAS)
Time frame: changes from baseline at 2 weeks
Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
pain severity(measured with a visual analogue scale, VAS)
Time frame: changes from baseline at 4 weeks
Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
12 secondary outcomes
SF-36
Time frame: changes from baseline at 2 weeks
Neck Disability Index（NDI）
Time frame: changes from baseline at 2 weeks
SF-36
Time frame: changes from baseline at 4 weeks
Neck Disability Index（NDI）
Time frame: changes from baseline at 4 weeks
Kidney function test
Time frame: changes from baseline at 4 weeks
Liver function test
Time frame: changes from baseline at 4 weeks
ECG
Time frame: changes from baseline at 4 weeks
Occult Blood
Time frame: changes from baseline at 4 weeks
Urine routine
Time frame: changes from baseline at 4 weeks
Blood routine
Time frame: changes from baseline at 4 weeks
Number of participants with Concomitant medication
Time frame: 4 weeks
Number of participants with Adverse Events
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2013.
- Derived from this study: PubMed 33881718Cui XJ, Sun YL, Zhang CQ, Wu T, Tan J, Zhu ZA, Chen YQ, Wang QG, Li M, Wang YJ. Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness. Chin J Integr Med. 2021 Jun;27(6):408-416. doi: 10.1007/s11655-021-2868-x. Epub 2021 Apr 21.
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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.
Xuejun Cui, Dr contact
Yongjun Wang, Dr principal investigator
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Qishe Pill in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 11 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 12 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xuejun Cui, Dr (13917715524@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity(measured with a visual analogue scale, VAS) (time frame: changes from baseline at 2 weeks). The study lists 2 primary outcomes in all. 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 NCT01875562, 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 12 Jun 2013.