Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063223) titled 'Clinical study for the effect of improving posture, pain, fatigue, sleep, and autonomic nervous system, intestinal environment by combination of chiropractic care, dietary supplement, exercise, and bedding in healthy Japanese: a pre-post comparison study' on Oct. 8.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Self control
Primary Sponsor:
Institute - national university corporation Tokushima University
Condition:
Condition - Healthy Japanese
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effect of improving physical function by combination of chiropractic care, dietary supplement, exercise, and bedding.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 -
Seven weeks
Chiropractic care (once a week) + consumption of the test food (every day, NANO CALFAMILY PLUS / CHONDRO MATE KARYU / HEALTH RESVERA / EUGLERA) + mattress (every day) + exercise {every day, BODY CONTROL BAND (BCB) / Physical Activity (PA)}
Test food: Consume NANO CALFAMILY PLUS (one packet per day), CHONDRO MATE KARYU (one packet per day), HEALTH RESVERA (one tablet per day), and EUGLERA (three tablets per day) with water
*The daily dose should be consumed within the same day. If a dose is missed, it should be consumed as soon as remembered.
Mattress: Invention of using mattress
Exercise: Invention of BCB and PA
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Female
Key inclusion criteria - 1. Japanese
2. Women
3. Individuals aged between 40 and 60
4. Healthy individuals
5. Individuals who have not undergone chiropractic care (for at least one year)
6. Individuals who are healthy adults with no significant past or current medical history and who have subjective symptoms (chief complaints) related to pain, fatigue, or sleep on daily
7. Individuals who have received an explanation of the study, and understand its content, and agree with its purpose, prior to participating in this study and who are able to obtain informed consent from the study participants based on their free will
Key exclusion criteria - 1. Individuals who are receiving treatment for malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for or have a history of any of the following chronic diseases:
cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, stroke disorder, lower extremity arterial disease, dyslipidemia, hypertension, neoplastic, hemorrhagic, infectious disease, amyotrophy disease, heart disease, disc herniation, ossification of the posterior longitudinal ligament, spondylosis deformans, spinal stenosis, osteoporosis, atlantoaxial subluxation, unstable spine, scoliosis, spina bifida, spondylolisthesis, or any other chronic diseases
4. Individuals who are allergic to medications or foods related to the test food
5. Individuals who have lactose intolerance
6. Individuals who have hereditary fructose intolerance
7. Individuals who have fructose malabsorption
8. Individuals who are pregnant, lactating, or planning pregnancy during this study
9. Individuals who suffer from COVID-19
10. Individuals who have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study
11. Individuals who are smokers
12. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target Size - 20
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 10 Month 07 Day
Date of IRB - 2026 Year 10 Month 07 Day
Anticipated trial start date - 2026 Year 10 Month 08 Day
Last follow-up date - 2026 Year 12 Month 16 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072364
Disclaimer: Curated by HT Syndication.