Tokyo, Sept. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062909) titled 'Effect of Repeated Subcutaneous NAD+ Injection on Sleep Quality' on Sept. 15.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Ohinata Clinic
Condition:
Condition - Sleep disturbance
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether repeated subcutaneous NAD+ injection differentially affects sleep quality according to baseline sleep status.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Subcutaneous injection of 200 mg NAD+ dissolved in normal saline with lidocaine, administered to the abdomen or buttock, once every 2 weeks for three courses (6 weeks of total dosing).
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - Adults aged 20 to 79 years with a self-reported sleep complaint (a non-symptomatic comparison subgroup was also enrolled following an ethics-committee-approved protocol amendment)
Key exclusion criteria - Severe hepatic impairment; pregnancy or breastfeeding; history of serious psychiatric illness; use of NMN or NAD+ within 1 month prior to enrollment.
Target Size - 20
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 06 Month 03 Day
Date of IRB - 2025 Year 06 Month 25 Day
Anticipated trial start date - 2025 Year 06 Month 03 Day
Last follow-up date - 2026 Year 01 Month 16 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072027
Disclaimer: Curated by HT Syndication.
