Qishe Pill for Cervical Radiculopathy

NCT01274936 | Unknown Phase 2 DMC

• 1 other identifier: Qishe
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (21)

• SF-36

  changes from baseline at 2 weeks

• Neck Disability Index（NDI）

  changes from baseline at 2 weeks

• Patient satisfaction degree

  Changes from baseline at 4 weeks

• SF-36

  changes from baseline at 4 weeks

• Neck Disability Index（NDI）

  changes from baseline at 4 weeks

Study Arms (2)

Qishe

EXPERIMENTAL

Drug: Qishe Pill

Control

PLACEBO COMPARATOR

Qishe Placebo

Drug: Qishe Placebo

Interventions

Qishe Pill DRUG

Pill, 3.75 g, twice per day, four weeks

Qishe

Qishe Placebo DRUG

Pill, 3.75 g, twice per day, four weeks

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• Fudan University: collaborator
• Changchun University of Chinese Medicine: collaborator
• Lanzhou Hospital of Traditional Chinese Medicine: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator

Study Sites (5)

No.1 Hospital, Changchun University of TCM

Changchun, China

COMPLETED

Gansu Hospital of TCM

Lanzhou, China

COMPLETED

Huadong Hospital

Shanghai, 200032, China

COMPLETED

Longhua Hospital

Shanghai, 200032, China

COMPLETED

Suzhou Hospital of TCM

Suzhou, China

RECRUITING

Related Publications (1)

• Cui XJ, Sun YL, You SF, Mo W, Lu S, Shi Q, Wang YJ. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials. 2013 Oct 7;14:322. doi: 10.1186/1745-6215-14-322.

  PMID: 24099350 DERIVED

MeSH Terms

Conditions

Radiculopathy

Interventions

qishe

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Yongjun Wang, Dr

  Longhua Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuejun Cui, Dr

CONTACT

13917715524@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: January 12, 2011
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

CN (5)