Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
240 participants
INTERVENTIONAL
2012-03-31
2015-06-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Qishe
Qishe Pill
Pill, 3.75 g, twice per day, four weeks
Control
Qishe Placebo
Qishe Placebo
Pill, 3.75 g, twice per day, four weeks
Interventions
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Qishe Pill
Pill, 3.75 g, twice per day, four weeks
Qishe Placebo
Pill, 3.75 g, twice per day, four weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
18 Years
65 Years
ALL
No
Sponsors
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Fudan University
OTHER
Changchun University of Chinese Medicine
OTHER
Lanzhou Hospital of Traditional Chinese Medicine
OTHER
Suzhou Hospital of Traditional Chinese Medicine
OTHER
Shanghai University of Traditional Chinese Medicine
OTHER
Responsible Party
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Cui xuejun
Vice director
Principal Investigators
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Yongjun Wang, Dr
Role: PRINCIPAL_INVESTIGATOR
Longhua Hospital
Locations
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No.1 Hospital, Changchun University of TCM
Changchun, , China
Gansu Hospital of TCM
Lanzhou, , China
Huadong Hospital
Shanghai, , China
Longhua Hospital
Shanghai, , China
Suzhou Hospital of TCM
Suzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Hong Jiang, PhD
Role: primary
Xiang Qin, Master
Role: backup
References
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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.
Other Identifiers
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Qishe
Identifier Type: -
Identifier Source: org_study_id