Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:30 AM
Study NCT ID:
NCT01274936
Status:
UNKNOWN
Last Update Posted:
2014-11-13
First Post:
2010-12-14
Brief Title:
Qishe Pill for Cervical Radiculopathy
Sponsor:
Shanghai University of Traditional Chinese Medicine
Organization:
Shanghai University of Traditional Chinese Medicine
Study Overview
Official Title:
Effectiveness of a Compound Traditional Chinese Herbal Medicine Qishe Pill on Cervical Radiculopathy a Randomized Double-blind Placebo-controlled Multicentre Trial
Status:
UNKNOWN
Status Verified Date:
2014-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 lifeHowever 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 surgeryIn 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 Fengwind Hancold Shidampness 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
As a complementary and alternative medicine CAM herbal medicines have the potential to avoid the adverse effects of medications and surgeryIn 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 Fengwind Hancold Shidampness 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None