Clinical research on neurotropin tablets in low back pain patients with sarcopenia
- Conditions
- ow back pain with sarcopenia
- Registration Number
- JPRN-jRCTs031220709
- Lead Sponsor
- Sumitani Masahiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
(1) Patients diagnosed with low back pain by the investigator
(2) Patients aged 65 or older at the time of obtaining consent
(3) Regardless of gender
(4) Patients who meet all of the following criteria
1. Grip strength
Less than 28 kg for male, less than 18 kg for female.
2. 4m walking speed
Walking speed <1.0m/s
3. Skeletal muscle mass
Less than 7.0 kg/m2 for male (BIA method)
Less than 5.4 kg/m2 for female (BIA method)
(5) Patients who have given written informed consent of their own free will after receiving a sufficient explanation for participating in this research
(6) Patients who are able to go to the outpatient clinic according to the study schedule
(7) Patients who can comply with the regulations for prohibited concomitant drugs and prohibited concomitant therapies (see ''7.4.1 Prohibited concomitant drugs and prohibited concomitant therapies'')
Those who meet even one of the following exclusion criteria will be excluded from subjects to be registered.
(1) Patients with a history of hypersensitivity to the study drug
(2) Patients with significant cognitive decline or mental illness
(3) Patients who have difficulty using devices used for efficacy evaluation due to their physique, etc.
(4) Patients who continue to administer preparations containing vaccinia virus-inoculated rabbit skin extract
(5) Patients whose results of laboratory tests meet the following conditions
1. ALT is 2.5 times or more of the upper limit of the reference value
2. AST is 2.5 times or more of the upper limit of the reference value
(6) Those who have participated in other clinical trials or clinical research (excluding observational studies) within 6 months prior to written consent
(7) Patients with diseases that should be prioritized for treatment other than frailty or sarcopenia due to low back pain
(8) In addition, those who are judged inappropriate to participate in this study by the principal investigator or co-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method