Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01875562
Recruitment Status : Unknown
Verified June 2013 by Cui xuejun, Shanghai University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : June 12, 2013
Last Update Posted : June 12, 2013
Sponsor:
Collaborators:
Huadong Hospital
Shanghai East Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Shanghai No.1 Hospital
Shanghai No.6 Hospital
Changhai Hospital
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE December 12, 2012
First Posted Date  ICMJE June 12, 2013
Last Update Posted Date June 12, 2013
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • 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 Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2013)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy
Official Title  ICMJE 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 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 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, listening, interrogation, and pulse-taking, TCM doctors can analyze the specific pathogenic factors which cause neck pain. Accordingly they can then prescribe herbal formulae based on the effect and the main indications according to the principles of Chinese medicine. Natural substances, including herbal medicines, have been 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Radiculopathy
Intervention  ICMJE Drug: Qishe Pill
Pill, 3.75 g, twice per day, four weeks
Study Arms  ICMJE Experimental: Qishe Pill
Intervention: Drug: Qishe Pill
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2013)
2400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Estimated Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01875562
Other Study ID Numbers  ICMJE PME of Qishe
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cui xuejun, Shanghai University of Traditional Chinese Medicine
Study Sponsor  ICMJE Shanghai University of Traditional Chinese Medicine
Collaborators  ICMJE
  • Huadong Hospital
  • Shanghai East Hospital
  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
  • Shanghai No.1 Hospital
  • Shanghai No.6 Hospital
  • Changhai Hospital
Investigators  ICMJE
Principal Investigator: Yongjun Wang, Dr Longhua Hospital
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP