Clinical Trial: A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

Brief 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 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 Summary:

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
Sponsor: Shanghai University of Traditional Chinese Medicine

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SF-36 [ Time Frame: changes from baseline at 2 weeks ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 2 weeks ]
    a composite of functional status
  • SF-36 [ Time Frame: changes from baseline at 4 weeks ]
    a composite of functional status
  • Neck Disability Index（NDI） [ Time Frame: changes from baseline at 4 weeks ]
    a composite of functional status
  • 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 ]


Original Secondary Outcome: Same as current

Information By: Shanghai University of Traditional Chinese Medicine

Dates:
Date Received: December 12, 2012
Date Started: May 2012
Date Completion: November 2013
Last Updated: June 11, 2013
Last Verified: June 2013