A placebo-controlled, randomized, double-blind study to evaluate the efficacy of Cistanche herb extract for cervical spondylotic myelopathy

Kawaguchi Yoshiharu0 sites50 target enrollmentDecember 21, 2020

Overview

No summary available.

Registry

who.int

Start Date

December 21, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kawaguchi Yoshiharu

•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.

•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.