Efficacy and safety of Guiqihuoxue Capsules in the treatment of different types of cervical spondylosis: a prospective, single-centered, open-ended, randomized controlled study

Phase 4

• Conditions: cervical spondylosis

• Registration Number: ITMCTR2200006439
• Lead Sponsor: The Second Hospital, Cheeloo College of Medicine, Shandong University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Male or female aged 18 to 70 years;
(2) From April 12, 2022 to October 11, 2023, patients were hospitalized in our department, and were diagnosed with cervical spondylosis after clinical manifestations combined with imaging examination;
(3) Those who have not received other related treatments within 1 month before treatment;
(4) Visual Analogue Scale (VAS) score is 3 to 8 points;
(5) Patients who voluntarily joined this study, had correct understanding and good compliance, and carefully read and understood the informed consent form and signed it.

Exclusion Criteria

(1) Those who have a history of surgery in the cervical spine lesion segment in the past or who have not undergone surgery for cervical spine lesion segment surgery to degenerate adjacent segments, or who have a history of major surgery in the past and may have unpredictable effects on the research results (such as organ transplantation, amputation, etc.);
(2) Patients with congenital malformations or scoliosis of the spine, previous spinal tuberculosis, patients with ankylosing spondylitis, rheumatoid spondylitis, malignant tumors after radiotherapy and chemotherapy or after resection or suspected tumors but not diagnosed, severe osteoporosis;
(3) Although the diagnosis of cervical spondylosis is clear, but at the same time suffering from cervical and shoulder myofasciitis, carpal or elbow syndrome, periarthritis of the shoulder joint, thoracic outlet syndrome and other diseases that can cause pain in the upper limbs, which can interfere with the study;
(4) Those who suffer from various chronic diseases, such as diabetes, various cardiovascular diseases, hypertension of grade 2 or above, cerebrovascular accident sequelae, etc. and need to take drugs for a long time;
(5) Pregnant women, lactating women, or women who are preparing to become pregnant in the near future;
(6) Identify those who suffer from various mental illnesses or have mental illnesses or suffer from organic diseases of the nervous system;
(7) Due to the needs of work and life, patients need to have too much time difference during the study period, or the environment
Those who travel to and from areas with too much difference;
(8) Patients who receive other clinical studies at the same time, or who have completed other clinical studies for less than 3 months.
(9) The researchers do not consider suitable for inclusion.

Study & Design

• Study Type: Treatment study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DI score;JOA score;mJOA score;