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

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01875562
• Other study ID #: PME of Qishe
• Status: Recruiting
• Phase: Phase 4
• First received: December 12, 2012
• Last updated: June 11, 2013
• Start date: May 2012
• Est. completion date: November 2013

Study information

• Verified date: June 2013
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Xuejun Cui, Dr
• Email: 13917715524[@]139.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Drug:
• Qishe Pill
Pill, 3.75 g, twice per day, four weeks

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of TCM	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	Changhai Hospital, Huadong Hospital, Shanghai East Hospital, Shanghai No.1 Hospital, Shanghai No.6 Hospital, Shanghai No.9 Hospital,Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain severity(measured with a visual analogue scale, VAS)	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.	changes from baseline at 2 weeks	No
Primary	pain severity(measured with a visual analogue scale, VAS)	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.	changes from baseline at 4 weeks	No
Secondary	SF-36	a composite of functional status	changes from baseline at 2 weeks	No
Secondary	Neck Disability Index(NDI)	a composite of functional status	changes from baseline at 2 weeks	No
Secondary	SF-36	a composite of functional status	changes from baseline at 4 weeks	No
Secondary	Neck Disability Index(NDI)	a composite of functional status	changes from baseline at 4 weeks	No
Secondary	Kidney function test		changes from baseline at 4 weeks	Yes
Secondary	Liver function test		changes from baseline at 4 weeks	Yes
Secondary	ECG		changes from baseline at 4 weeks	Yes
Secondary	Occult Blood		changes from baseline at 4 weeks	Yes
Secondary	Urine routine		changes from baseline at 4 weeks	Yes
Secondary	Blood routine		changes from baseline at 4 weeks	Yes
Secondary	Number of participants with Concomitant medication		4 weeks
Secondary	Number of participants with Adverse Events		4 weeks