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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Huadong Hospital, Fudan University
Shanghai East Hospital
Shanghai No.9 Hospital,Jiaotong University
Shanghai Hospital of TCM
Shanghai No.1 Hospital
Shanghai No.6 Hospital
Changhai Hospital, Second Military Medical University
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01875562
First received: December 12, 2012
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Cervical Radiculopathy
Drug: Qishe Pill
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Post-marketing Evaluation of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy

Resource links provided by NLM:


Further study details as provided by Shanghai University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • pain severity(measured with a visual analogue scale, VAS) [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • SF-36 [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: No ]
    a composite of functional status

  • Neck Disability Index(NDI) [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: No ]
    a composite of functional status

  • SF-36 [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
    a composite of functional status

  • Neck Disability Index(NDI) [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
    a composite of functional status

  • Kidney function test [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • Liver function test [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • ECG [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • Occult Blood [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • Urine routine [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • Blood routine [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with Concomitant medication [ Time Frame: 4 weeks ]
  • Number of participants with Adverse Events [ Time Frame: 4 weeks ]

Estimated Enrollment: 2400
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qishe Pill Drug: Qishe Pill
Pill, 3.75 g, twice per day, four weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01875562

Contacts
Contact: Xuejun Cui, Dr 13917715524@139.com

Locations
China, Shanghai
Longhua Hospital, Shanghai University of TCM Recruiting
Shanghai, Shanghai, China, 200032
Contact: Xuejun Cui, Dr       13917715524@139.com   
Contact: Wen Mo, Dr         
Principal Investigator: Yongjun Wang, Dr         
Sub-Investigator: Wen Mo, Dr         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Huadong Hospital, Fudan University
Shanghai East Hospital
Shanghai No.9 Hospital,Jiaotong University
Shanghai Hospital of TCM
Shanghai No.1 Hospital
Shanghai No.6 Hospital
Changhai Hospital, Second Military Medical University
Investigators
Principal Investigator: Yongjun Wang, Dr Longhua Hospital
  More Information

No publications provided

Responsible Party: Cui xuejun, Vice director, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01875562     History of Changes
Other Study ID Numbers: PME of Qishe
Study First Received: December 12, 2012
Last Updated: June 11, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai University of Traditional Chinese Medicine:
Neck pain
Cervical radiculopathy
Qishe Pill
Traditional Chinese Medicine

Additional relevant MeSH terms:
Physiological Effects of Drugs
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014