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Efficiency of GliSODi

Not Applicable
Conditions
ocomotive syndrome
Registration Number
JPRN-jRCTs031180310
Lead Sponsor
Koike Masato
Brief Summary

Oral administration of GliSODin improved subjective symptoms, decreased TNFa, increased ucOC, and decreased body fat percentage in patients with locomotive syndrome, we found that GliSODin was effective in preventing and improving locomotive syndrome.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
46
Inclusion Criteria

Volunteer with low back or knee pain and gait instability caused by motor weakness

Exclusion Criteria

Volunteer with diseases including internal medicine, psychogenic disorders, neuromuscular diseases, postoperative state of orthopaedic surgery, allergy against wheat and melon

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Questionnaires on subjective symptoms (Health-related QOL SF-36, Japanese Orthopedic Surgery Association Low Back Pain Disease Questionnaire (JOABPEQ), Functional Assessment Scale for Osteoarthritis Patients (JKOM), Locomo 25 (Activity Evaluation Indicator), Motor Function (Grip strength, coordination function evaluation, walking speed), Chalder Fatigue Scale
Secondary Outcome Measures
NameTimeMethod
Presence or absence of side effects due to long-term oral administration: Liver function (AST, ALT), Renal function (BUN, Cr)<br>Oxidative stress markers (blood oxidative stress level dROMs, blood antioxidant power BAP, blood SOD activity), Whole body DEXA (muscle mass, fat mass), Bone density bone formation marker P1NP, Bone resorption marker TRACP 5b, X-ray of knee joint and lumbar spine)
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