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

NCT01875562 | Unknown Phase 4 DMC

• 1 other identifier: PME of Qishe
• Study Type: interventional
• Target: 2,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Radiculopathy

Keywords

Neck pain; Cervical radiculopathy; Qishe Pill; Traditional Chinese Medicine

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 (12)

• SF-36

  changes from baseline at 2 weeks

• Neck Disability Index（NDI）

  changes from baseline at 2 weeks

• SF-36

  changes from baseline at 4 weeks

• Neck Disability Index（NDI）

  changes from baseline at 4 weeks

• Kidney function test

  changes from baseline at 4 weeks

Study Arms (1)

Qishe Pill

EXPERIMENTAL

Drug: Qishe Pill

Interventions

Qishe Pill DRUG

Pill, 3.75 g, twice per day, four weeks

Qishe Pill

Eligibility Criteria

• Age: 18 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
• Huadong Hospital: collaborator
• Shanghai East Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Shanghai No.1 Hospital: collaborator
• Shanghai No.6 Hospital: collaborator
• Changhai Hospital: collaborator

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 33881718 DERIVED

MeSH Terms

Conditions

Radiculopathy; Neck Pain

Interventions

qishe

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice director

Study Record Dates

• First Submitted: December 12, 2012
• First Posted: June 12, 2013
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

CN (1)