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Qishe Pill for Cervical Radiculopathy

NCT01274936 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2014-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Cervical Radiculopathy

Interventions

DRUG

Qishe Pill

Pill, 3.75 g, twice per day, four weeks

DRUG

Qishe Placebo

Pill, 3.75 g, twice per day, four weeks

Sponsors & Collaborators

  • Fudan University

    collaborator OTHER

  • Changchun University of Chinese Medicine

    collaborator OTHER

  • Lanzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Suzhou Hospital of Traditional Chinese Medicine

    collaborator OTHER

  • Shanghai University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Yongjun Wang, Dr · Longhua Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-02-28
Completion
2015-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01274936 on ClinicalTrials.gov