Clinical study of Cistanche herb extract for cervical spondylotic myelopathy

JRCT ID: jRCTs041200080

Registered date:21/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical spondylotic myelopathy
• Date of first enrollment: 21/12/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Intake of Cistanche herb extract

Outcome(s)

Primary Outcome

1) Calculate the total score of the cervical spine JOA score (Japan Orthopedic Cervical Myelopathy Treatment Criteria) and JOACMEQ (JOA Cervical Myelopathy Evaluation Questionnaire), and calculate the total score before, 12 weeks (3 months), 24 weeks (6 months) after administration. Calculate the amount of change
in the score at the time of and compare between the groups.
2) Physical examination findings (number of 10-second tests, grip strength) before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after administration. Calculate the amount of change in the score and compare between the groups.
3) Calculate the total score of EQ-5D (Japanese version EuroQol), and the amount of change in the score
before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after
administration. Calculate the amount of change in the score and compare between the groups.
4) Calculate VAS, and the amount of change in the score before administration, before administration, 12 weeks (3 months) and 24 weeks (6 months) after administration. Calculate the amount of change in the score and compare between the groups.

• Secondary Outcome: 1) Simple X-ray, MRI

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawaguchi Yoshiharu
• Secondary Sponsor: Tohda Chihiro