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Trial record 18 of 113 for:    herbal medicine | Open Studies

Qishe Pill for Cervical Radiculopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Shanghai University of Traditional Chinese Medicine
Sponsor:
Collaborators:
Fudan University
No.1 Hospital, Changchun University of TCM
Lanzhou Hospital of TCM
Suzhou Hospital of TCM
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01274936
First received: December 14, 2010
Last updated: November 11, 2014
Last verified: November 2014
  Purpose

Radiculopathy generally presents with pain, numbness, or weakness in a dermatomal distribution. Cervical radiculopathy results from impingement on a nerve root by either spondylotic narrowing of the neural foramen or a lateral intervertebral disc herniation. Specifically, it should be the goal of the treating physician to relieve pain, improve function, and prevent recurrence. Various studies have shown that nonoperative management of cervical radiculopathy leaves a substantial minority of patients with persistently troublesome symptoms. Pharmacologic agents treat the underlying condition and provide symptomatic relief. The various classes of medications used to treat radiculopathy include steroids, nonsteroidal antiinflammatory drugs (NSAIDs), muscle relaxants, narcotics, and antidepressants. Herbal medicines have been used for centuries in China. In China, many patients with cervical disc disease are increasingly turning to herbal medicines to alleviate their symptoms and reduce the side effects of medications. The goal of this study is to determine the efficacy and efficacy of an herbal medicine, Qishe Pill, to treat cervical radiculopathy.


Condition Intervention Phase
Cervical Radiculopathy
Drug: Qishe Pill
Drug: Qishe Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

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

  • Patient satisfaction degree [ Time Frame: Changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
    To evaluate satisfaction

  • 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

  • Neck Disability Index(NDI) [ Time Frame: changes from baseline at 3 months ] [ Designated as safety issue: No ]
    a composite of functional status

  • Neck Disability Index(NDI) [ Time Frame: changes from baseline at 6 months ] [ Designated as safety issue: No ]
    a composite of functional status

  • Safety evaluation [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: Yes ]
    Safety evaluation

  • The medicine issue [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: Yes ]
  • Compliance assessment [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: No ]
    To evaluate compliance

  • Compliance assessment [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
    To evaluate compliance

  • Concomitant medication [ Time Frame: changes from baseline at 2 weeks ] [ Designated as safety issue: No ]
  • Concomitant medication [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
  • X-ray(frontal and lateral) [ Time Frame: changes from baseline at 4 weeks ] [ Designated as safety issue: No ]
  • 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 ]
  • Excrement routine [ 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 ]

Estimated Enrollment: 240
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Qishe Drug: Qishe Pill
Pill, 3.75 g, twice per day, four weeks
Placebo Comparator: Control
Qishe Placebo
Drug: Qishe Placebo
Pill, 3.75 g, twice per day, four weeks
Other Name: Qishe Placebo

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 spondylopathy radiculopathy is nearly the same that the nonspecific neck or back pain can be found in most of 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 generally is no randomized, placebo-controlled trial available comparing the standard nonsurgical treatments. 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.In the basic theory of traditional Chinese medicine (TCM), the obstruction of Qi flow and blood circulation in the neck area caused by some 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, on patients, TCM doctors can analyze the certain pathogenic factors which cause neck pain. And then they will prescribe herbal formulae based on the effect and the main indications of Chinese medicine. Natural substances, including herbal medicines, have being 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.

A number of studies on the effects of the Chinese herbal medicine on cervical radiculopathy have been proposed, but useful empirical research is insufficiency. For chronic neck pain with or without radicular symptoms, there is low quality evidence that herbal is more effective than placebo for pain relief, which is measured at the end of the treatment. However, the size of the studies was small and the effect was measured in the short-term. Further research is very likely to change both the effect size and our confidence in the results. There is a need for trials with adequate numbers of participants that address long-term efficacy or effectiveness of herbal medicine compared to placebo.

Qishe Pill is composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, Calculus Bovis Artifactus. Using a well-designed clinical trial, we will survey the effectiveness of concurrent use of this remedy in relieving neck pain. Therefore, the present study is to examine effectiveness and safety of Qishe Pill, a compound traditional Chinese herbal medicine, on neck pain in cervical spondylotic radiculopathy in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Qishe Pill as an intervention to alleviate neck pain caused by cervical radiculopathy.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
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: NCT01274936

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

Locations
China
No.1 Hospital, Changchun University of TCM Completed
Changchun, China
Gansu Hospital of TCM Completed
Lanzhou, China
Huadong Hospital Completed
Shanghai, China, 200032
Longhua Hospital Completed
Shanghai, China, 200032
Suzhou Hospital of TCM Recruiting
Suzhou, China
Contact: Hong Jiang, PhD         
Contact: Xiang Qin, Master         
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
Fudan University
No.1 Hospital, Changchun University of TCM
Lanzhou Hospital of TCM
Suzhou Hospital of TCM
Investigators
Principal Investigator: Yongjun Wang, Dr Longhua Hospital
  More Information

No publications provided by Shanghai University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cui xuejun, Vice director, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01274936     History of Changes
Other Study ID Numbers: Qishe
Study First Received: December 14, 2010
Last Updated: November 11, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014