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

NCT ID: NCT01875562

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-11-30

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.

Conditions

Cervical Radiculopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Qishe Pill

Group Type: EXPERIMENTAL

Qishe Pill

Intervention Type: DRUG

Pill, 3.75 g, twice per day, four weeks

Interventions

Qishe Pill

Pill, 3.75 g, twice per day, four weeks

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huadong Hospital

OTHER

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: collaborator

Shanghai No.1 Hospital

UNKNOWN

Sponsor Role: collaborator

Shanghai No.6 Hospital

UNKNOWN

Sponsor Role: collaborator

Changhai Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Cui xuejun

Vice director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongjun Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Longhua Hospital

Locations

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuejun Cui, Dr

Role: CONTACT

13917715524@139.com

Facility Contacts

Xuejun Cui, Dr

Role: primary

13917715524@139.com

Wen Mo, Dr

Role: backup

References

Cui XJ, Sun YL, Zhang CQ, Wu T, Tan J, Zhu ZA, Chen YQ, Wang QG, Li M, Wang YJ. Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness. Chin J Integr Med. 2021 Jun;27(6):408-416. doi: 10.1007/s11655-021-2868-x. Epub 2021 Apr 21.

Reference Type: DERIVED

PMID: 33881718 (View on PubMed)

Other Identifiers

PME of Qishe

Identifier Type: -

Identifier Source: org_study_id