Tokyo, Nov. 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059771) titled 'Evaluation of Somatic-Visceral Reflexes Associated with Back Heat Therapy Using Bowel Sounds and Heart Rate Variability Analysis;A randomized controlled trial' on Nov. 20.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Takasaki University of Health and Welfare
Condition:
Condition - Healthy adult women with constipation
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Evaluation of Somatic-Visceral Reflexes Associated with Lumbar-Dorsal Heat Therapy Using Bowel Sounds and Heart Rate Variability (HRV) Analysis
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Intervention group 1 (thoracic vertebrae group)
This group applies a warm compress for 10 minutes to the area 10 cm above the 12th thoracic vertebra.
Interventions/Control_2 - Intervention group 2 (lumbar vertebrae group)
This group applies a warm compress for 10 minutes
to a 10 cm wide area centered on the Jacoby line(the line connecting the left and right iliac crests).
Eligibility:
Age-lower limit - 18
years-old
Gender - Female
Key inclusion criteria - Healthy women aged 18 to under 30 who are aware of constipation.
Key exclusion criteria - (1) Those who are in the hospital or receiving medication due to an underlying disease.
(2) Those with circulatory system abnormalities.
(3) Persons with bleeding tendency.
(4) Those with abnormalities in the skin of the lower back.
Target Size - 31
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 10 Month 24 Day
Date of IRB - 2025 Year 10 Month 31 Day
Anticipated trial start date - 2025 Year 11 Month 27 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068344
Disclaimer: Curated by HT Syndication.
