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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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

13917715524@139.com

5 sites in 1 country

China5 sites, 1 recruiting
  • No.1 Hospital, Changchun University of TCM

    Changchun

    Completed
  • Gansu Hospital of TCM

    Lanzhou

    Completed
  • Huadong Hospital

    Shanghai, 200032

    Completed
  • Longhua Hospital

    Shanghai, 200032

    Completed
  • Suzhou Hospital of TCM

    Suzhou

    Hong Jiang, PhD

    Xiang Qin, Master

    Recruiting

Other trials in China

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.

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 groups in NCT01274936
Study groupRoleWhat they receive
QisheExperimentalNot described
Receives: Drug: Qishe Pill
ControlPlacebo comparatorQishe Placebo
Receives: Drug: Qishe Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. SF-36

    a composite of functional status

    Measured: changes from baseline at 2 weeks

  2. Neck Disability Index(NDI)

    a composite of functional status

    Measured: changes from baseline at 2 weeks

  3. Patient satisfaction degree

    To evaluate satisfaction

    Measured: Changes from baseline at 4 weeks

  4. SF-36

    a composite of functional status

    Measured: changes from baseline at 4 weeks

  5. Neck Disability Index(NDI)

    a composite of functional status

    Measured: changes from baseline at 4 weeks

  6. Neck Disability Index(NDI)

    a composite of functional status

    Measured: changes from baseline at 3 months

  7. Neck Disability Index(NDI)

    a composite of functional status

    Measured: changes from baseline at 6 months

  8. Safety evaluation

    Safety evaluation

    Measured: changes from baseline at 4 weeks

  9. The medicine issue

    Measured: changes from baseline at 2 weeks

  10. Compliance assessment

    To evaluate compliance

    Measured: changes from baseline at 2 weeks

  11. Compliance assessment

    To evaluate compliance

    Measured: changes from baseline at 4 weeks

  12. Concomitant medication

    Measured: changes from baseline at 2 weeks

  13. Concomitant medication

    Measured: changes from baseline at 4 weeks

  14. X-ray(frontal and lateral)

    Measured: changes from baseline at 4 weeks

  15. Kidney function test

    Measured: changes from baseline at 4 weeks

  16. Liver function test

    Measured: changes from baseline at 4 weeks

  17. ECG

    Measured: changes from baseline at 4 weeks

  18. Occult Blood

    Measured: changes from baseline at 4 weeks

  19. Excrement routine

    Measured: changes from baseline at 4 weeks

  20. Urine routine

    Measured: changes from baseline at 4 weeks

  21. 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.

  1. First posted12 Jan 2011 (estimated)
  2. Study startMar 2012
  3. Primary completionFeb 2015 (estimated)
  4. Study completionJun 2015 (estimated)

Resources

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)
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

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.

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