Clinical efficiency of transoral administration of GliSODin against aging-related dysfunction in motor organ.

A Double Blind, Randomized Placebo-Controlled Study of Clinical Efficacy of Melon-GliSODin for the Treatment of Aging-related Dysfunction in Motor Organs - Efficiency of GliSODin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025163

Enrollment

Registered

2016-12-09

Start date

2016-12-09

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locomotive Syndrome

Interventions

GliSODin(1,000 IU/day) for 6 months Placebo for 6 months

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Volunteer with diseases including internal midicine, psychogenic disorders, neuromuscular diseases, postoperative state of orthopaedic surgery, allergy against melon and wheat.

Design outcomes

Primary

Measure	Time frame
Questionnaire on subjective symptoms (Health-related QOL SF-36, Japanese Orthopedic Surgery Association Low Back Pain Disease Questionnaire (JOABPEQ), Japanese Knee Osteoarthritis Measure (JKOM), Locomo 25 Roland-Morris Disability questionnaire (RDQ),disease-specific assessment method for back pain while standing(Oswestry Disability index; ODI), Chalder fatigue Scale,Verbal Rating Scale (VRS), and motility function (grip strength, leg strength, timed up-and go test (TUG), 6-minute walking distance, the two step test, the stand-up test)	—

Measure

Time frame

Questionnaire on subjective symptoms (Health-related QOL SF-36, Japanese Orthopedic Surgery Association Low Back Pain Disease Questionnaire (JOABPEQ), Japanese Knee Osteoarthritis Measure (JKOM), Locomo 25 Roland-Morris Disability questionnaire (RDQ),disease-specific assessment method for back pain while standing(Oswestry Disability index; ODI), Chalder fatigue Scale,Verbal Rating Scale (VRS), and motility function (grip strength, leg strength, timed up-and go test (TUG), 6-minute walking distance, the two step test, the stand-up test)

—

Secondary

Measure	Time frame
renal function (urea nitrogen (BUN) and serum creatinine (Cre)), liver damage (serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)), bone formation (procollagen type 1 nitrogenous propeptides (P1NP)), bone resorption (tartrate-resistant acid phosphatase 5b (TRACP5b), osteocalcin (OC), and undercarboxylated osteocalcin (ucOC)), and oxidation (diacron-reactive oxygen metabolites (dROMs) and malondialdehyde (MDA)); antioxidant enzymes (superoxide dismutase (SOD), glutathione peroxidase (GPx), and biological antioxidant potential (BAP)); a marker of glycation (pentosidine); inflammatory cytokines (interleukin-6 (IL6), TNFa, high-sensitivity C-reactive protein (hsCRP), and matrix metalloproteinase 3 (MMP3)). Furthermore, bone density (hip joint Young Adult Mean (YAM), lumbar spine YAM, and whole-body YAM), the Skeletal Muscle Index (SMI), body fat percentage, fat mass, non-fat mass, android (A) fat, gynoid (G) fat; the white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and platelet (Plt) count. The biochemical tests comprised serum total protein (TP), albumin (Alb), CK, uric acid (UA) glucose, Zn, Cu, Ca, and Pi	—

Measure

Time frame

renal function (urea nitrogen (BUN) and serum creatinine (Cre)), liver damage (serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)), bone formation (procollagen type 1 nitrogenous propeptides (P1NP)), bone resorption (tartrate-resistant acid phosphatase 5b (TRACP5b), osteocalcin (OC), and undercarboxylated osteocalcin (ucOC)), and oxidation (diacron-reactive oxygen metabolites (dROMs) and malondialdehyde (MDA)); antioxidant enzymes (superoxide dismutase (SOD), glutathione peroxidase (GPx), and biological antioxidant potential (BAP)); a marker of glycation (pentosidine); inflammatory cytokines (interleukin-6 (IL6), TNFa, high-sensitivity C-reactive protein (hsCRP), and matrix metalloproteinase 3 (MMP3)). Furthermore, bone density (hip joint Young Adult Mean (YAM), lumbar spine YAM, and whole-body YAM), the Skeletal Muscle Index (SMI), body fat percentage, fat mass, non-fat mass, android (A) fat, gynoid (G) fat; the white blood cell (WBC) count, red blood cell (RBC) count, hemoglobin (Hb), hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean cell hemoglobin concentration (MCHC), and platelet (Plt) count. The biochemical tests comprised serum total protein (TP), albumin (Alb), CK, uric acid (UA) glucose, Zn, Cu, Ca, and Pi

—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactMasato Koike

Juntendo Tokyo Koto Geriatric Medical Center Department of Orthopaedic Surgery

ortho-m.koike@juntendo.ac.jp03-5632-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026