Cervical RadiculopathyPhase 2NCT01274936
Qishe Pill for Cervical Radiculopathy
A Phase 2 study testing Qishe Pill in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine at 5 sites in China.
Trial summary
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 5 sitesChina
- Study dates
- Mar 2012to Jun 2015
- Phase
- Phase 2
- 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 65 years
- 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
5 sites in 1 country.
Xuejun Cui, Dr contact
5 sites in 1 country
China5 sites, 1 recruiting
- Completed
No.1 Hospital, Changchun University of TCM
Changchun
- Completed
Gansu Hospital of TCM
Lanzhou
- Completed
Huadong Hospital
Shanghai, 200032
- Completed
Longhua Hospital
Shanghai, 200032
- Recruiting
Suzhou Hospital of TCM
Suzhou
Hong Jiang, PhD
Xiang Qin, Master
About this study
Official title: Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms. Pharmacologic agents treat the underlying condition and provide symptomatic relief. The various classes of medications used to treat radiculopathy include steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and antidepressants. Herbal medicines have been used for centuries in China. In China, many patients with cervical disc disease are increasingly turning to herbal medicines to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat 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 spondylopathy radiculopathy is nearly the same that the nonspecific neck or back pain can be found in most of 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 generally is no randomized, placebo-controlled trial available comparing the standard nonsurgical treatments. 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.In the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by some 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, on patients, TCM doctors can analyze the certain pathogenic factors which cause neck pain. And then they will prescribe herbal formulae based on the effect and the main indications of Chinese medicine. Natural substances, including herbal medicines, have being 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.
A number of studies on the effects of the Chinese herbal medicine on cervical radiculopathy have been proposed, but useful empirical research is insufficiency. For chronic neck pain with or without radicular symptoms, there is low quality evidence that herbal is more effective than placebo for pain relief, which is measured at the end of the treatment. However, the size of the studies was small and the effect was measured in the short-term. Further research is very likely to change both the effect size and our confidence in the results. There is a need for trials with adequate numbers of participants that address long-term efficacy or effectiveness of herbal medicine compared to placebo.
Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, Calculus Bovis Artifactus. Using a well-designed clinical trial, we will survey the effectiveness of concurrent use of this remedy in relieving neck pain. Therefore, the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, on neck pain in cervical spondylotic radiculopathy in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Qishe Pill as an intervention to alleviate neck pain caused by cervical radiculopathy.
- Conditions
- Cervical Radiculopathy
- Being tested
- Qishe Pill, Qishe Placebo
- Medical subject headings
- Radiculopathy
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
Qishe PlaceboDrug
Pill, 3.75 g, twice per day, four weeks
| Study group | Role | What they receive |
|---|---|---|
| Qishe | Experimental | Not described Receives: Drug: Qishe Pill |
| Control | Placebo comparator | Qishe Placebo Receives: Drug: Qishe Placebo |
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 (21)
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
Patient satisfaction degree
To evaluate satisfaction
Measured: Changes from baseline at 4 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
Neck Disability Index(NDI)
a composite of functional status
Measured: changes from baseline at 3 months
Neck Disability Index(NDI)
a composite of functional status
Measured: changes from baseline at 6 months
Safety evaluation
Safety evaluation
Measured: changes from baseline at 4 weeks
The medicine issue
Measured: changes from baseline at 2 weeks
Compliance assessment
To evaluate compliance
Measured: changes from baseline at 2 weeks
Compliance assessment
To evaluate compliance
Measured: changes from baseline at 4 weeks
Concomitant medication
Measured: changes from baseline at 2 weeks
Concomitant medication
Measured: changes from baseline at 4 weeks
X-ray(frontal and lateral)
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
Excrement routine
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startMar 2012
- Primary completionFeb 2015 (estimated)
- Study completionJun 2015 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Changchun University of Chinese Medicine, Lanzhou Hospital of Traditional Chinese Medicine, Suzhou Hospital of Traditional Chinese Medicine
- 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
- NCT01274936
- Sponsor's protocol ID
- Qishe
- Status last verified
- Nov 2014
- First submitted
- 14 Dec 2010
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cui XJ, Sun YL, You SF, Mo W, Lu S, Shi Q, Wang YJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:322. doi: 10.1186/1745-6215-14-322.
PubMed 24099350
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial
- ClinicalTrials.gov ID
- NCT01274936
- Acronym / sponsor ID
- Qishe
- Conditions
- Cervical Radiculopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Fudan University, Changchun University of Chinese Medicine, Lanzhou Hospital of Traditional Chinese Medicine, Suzhou Hospital of Traditional Chinese Medicine
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 12 Jan 2011 (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.
Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms. Pharmacologic agents treat the underlying condition and provide symptomatic relief. The various classes of medications used to treat radiculopathy include steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and antidepressants. Herbal medicines have been used for centuries in China. In China, many patients with cervical disc disease are increasingly turning to herbal medicines to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat 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 spondylopathy radiculopathy is nearly the same that the nonspecific neck or back pain can be found in most of 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 generally is no randomized, placebo-controlled trial available comparing the standard nonsurgical treatments. 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.In the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by some 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, on patients, TCM doctors can analyze the certain pathogenic factors which cause neck pain. And then they will prescribe herbal formulae based on the effect and the main indications of Chinese medicine. Natural substances, including herbal medicines, have being 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.
A number of studies on the effects of the Chinese herbal medicine on cervical radiculopathy have been proposed, but useful empirical research is insufficiency. For chronic neck pain with or without radicular symptoms, there is low quality evidence that herbal is more effective than placebo for pain relief, which is measured at the end of the treatment. However, the size of the studies was small and the effect was measured in the short-term. Further research is very likely to change both the effect size and our confidence in the results. There is a need for trials with adequate numbers of participants that address long-term efficacy or effectiveness of herbal medicine compared to placebo.
Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, Calculus Bovis Artifactus. Using a well-designed clinical trial, we will survey the effectiveness of concurrent use of this remedy in relieving neck pain. Therefore, the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, on neck pain in cervical spondylotic radiculopathy in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Qishe Pill as an intervention to alleviate neck pain caused by cervical radiculopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qishe | Experimental | Drug: Qishe Pill |
| Control | Placebo comparator | Drug: Qishe PlaceboQishe Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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 |
| Qishe PlaceboPill, 3.75 g, twice per day, four weeks | Drug | Control |
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.
21 secondary outcomes
SF-36
Time frame: changes from baseline at 2 weeks
Neck Disability Index(NDI)
Time frame: changes from baseline at 2 weeks
Patient satisfaction degree
Time frame: Changes from baseline at 4 weeks
SF-36
Time frame: changes from baseline at 4 weeks
Neck Disability Index(NDI)
Time frame: changes from baseline at 4 weeks
Neck Disability Index(NDI)
Time frame: changes from baseline at 3 months
Neck Disability Index(NDI)
Time frame: changes from baseline at 6 months
Safety evaluation
Time frame: changes from baseline at 4 weeks
The medicine issue
Time frame: changes from baseline at 2 weeks
Compliance assessment
Time frame: changes from baseline at 2 weeks
Compliance assessment
Time frame: changes from baseline at 4 weeks
Concomitant medication
Time frame: changes from baseline at 2 weeks
Concomitant medication
Time frame: changes from baseline at 4 weeks
X-ray(frontal and lateral)
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
Excrement routine
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Derived from this study: PubMed 24099350Cui XJ, Sun YL, You SF, Mo W, Lu S, Shi Q, Wang YJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:322. doi: 10.1186/1745-6215-14-322.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Qishe Pill in people with Cervical Radiculopathy, run by Shanghai University of Traditional Chinese Medicine at 5 sites 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 5 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 NCT01274936, 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 13 Nov 2014; AzTrials last refreshed its copy on 4 Nov 2026.