Clinical study of Cistanche herb extract for cervical spondylotic myelopathy

Phase 1

Recruiting

• Conditions: Cervical spondylotic myelopathy

• Registration Number: JPRN-jRCTs041200080
• Lead Sponsor: Kawaguchi Yoshiharu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) Those whose age at consent date is 40 years - 85 years.
2) Those who can participate in the inspection conducted on the University of Toyama Sugitani Campus.
3) Those who meet the diagnostic criteria for cervical spondylotic myelopathy by physical examination.
4) Those who have a cervical spine JOA score of 8 points or more and 15 points or less at the time of screening.
5) Those who agree to provide blood samples for clinical examination.
6) The person can take the test drug, and the person or family member can manage to intake the drug.
7) Those who agree not to make extreme changes in lifestyle such as exercise habits and eating habits
during the test period.

Exclusion Criteria

1) Patients who do not agree.
2) Those who was in uncontrolled and clinically problematic health conditions (diabetes, hypertension,
thyroid / endocrine disorders, congestive heart failure, angina, heart disease, cancer risk such as breast
cancer, uterine cancer, or ovarian cancer, gastrointestinal disease, dialysis or renal dysfunction, etc.) within 3 months of consent.
3) Those with a history of alcohol and substance abuse.
4) Those who are participating in other intervention clinical trials.
5) Those with a cervical spinal cord JOA score of 16 points or more at the time of screening and very mild
cervical spondylotic myelopathy.
6) Those who have a cervical spinal cord JOA score of 7 points or less at the time of screening and who
have serious cervical spondylotic myelopathy and who are judged to require early surgery.
7) In addition, those who are judged by the researcher to be inappropriate as subjects.

Study & Design

• Study Type: Interventional
• Study Design: Not specified