Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062302) titled 'A Study on the Efficacy of Wearing Daytime Compression Stockings
--An Open-Label Crossover Comparative Trial--' on July 22.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - TES Holdings Co., Ltd.
Condition:
Condition - No
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to evaluate and assess the efficacy (alleviation of swelling, etc.) of wearing the test product (daytime compression stockings).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - [1] Wearing the test product (single use, prolonged sitting test)
[2] Measurement
[3] Washout period (6 days or more)
[4] Not wearing the test product (prolonged sitting test)
[5] Measurement
Interventions/Control_2 - [1] Not wearing the test product (prolonged sitting test)
[2] Measurement
[3] Washout period (6 days or more)
[4] Wearing the test product (single use, prolonged sitting test)
[5] Measurement
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - 1) Women aged 18 or older but under 60 at the time of obtaining consent to participate in the study.
2) Individuals with a BMI of 18.5 kg/m2 or higher but less than 25.0 kg/m2.
3) Individuals whose leg swelling does not subside upon waking (e.g., marks from socks or similar items tend to remain).
4) Individuals who agree not to use any swelling-relief therapies-such as massage devices or other compression socks during the study period.
5) Healthy individuals with no chronic physical conditions, including skin diseases.
6) Individuals whose daily routines will not become irregular from one week before the test until the test is completed.
7) Individuals who consent to the use of the test results in academic society publications or corporate advertisements in a form that does not identify specific individuals.
8) Individuals who have received a thorough explanation of the purpose and content of this trial, possess the capacity to give informed consent, have voluntarily applied to participate after fully understanding the details, and are able to provide written consent to participate in this trial.
9) Individuals who are able to visit the facility on the designated examination date, strictly adhere to the guidelines, and undergo the examination.
10) Individuals whom the principal investigator deems suitable for participation in this trial.
Key exclusion criteria - Individuals
1) with chronic diseases or those currently undergoing treatment for any medical condition.
2) with a current or clinically significant history of arterial circulatory disorders, congestive heart failure, painful phlegmasia, infectious phlebitis, deep vein thrombosis, chronic fatigue syndrome, mental or sleep disorders, hypertension, diabetes, dyslipidemia, lower extremity varicose veins, or lumbar spinal stenosis.
3) with a current or past history of severe conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system.
4) with severe anemia.
5) with symptoms of skin conditions such as atopic dermatitis.
6) with metal allergies or hypersensitivity to fibers.
7) with severe leg deformities, lower limb disorders, inflammatory or suppurative diseases, acute wounds or inflammation, or sensory or neurological disorders.
8) taking oral contraceptives.
9) who have taken or applied medication for the treatment of a medical condition within the past month.
10) who routinely use elastic stockings, compression socks, or calf supports in their daily lives.
11) currently or recently (within 1 month) consuming FOSHU, foods with functional claims, or health foods, and those planning to consume them during the study.
12) whose daily alcohol consumption, calculated as pure alcohol, exceeds an average of 20 g per day.
13) who smoke.
14) who engage in high-intensity exercise on a regular basis and those who are currently dieting.
15) Night shift workers.
16) who are pregnant, breastfeeding, or who may become pregnant during the study.
17) with irregular lifestyle or dietary habits, or those likely to change their lifestyle during the study.
18) currently participating in another human clinical trial, or who participated in one within the past month.
19) Any other individuals deemed ineligible for this trial by the principal investigator.
Target Size - 25
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 07 Day
Date of IRB - 2026 Year 07 Month 08 Day
Anticipated trial start date - 2026 Year 07 Month 23 Day
Last follow-up date - 2026 Year 07 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071160
Disclaimer: Curated by HT Syndication.
