A Single-Arm Single Blind Multicenter Interventional Study To Evaluate The Efficacy And Safety Of Naturopathic Sleeping Products in Peri/Menopause Women Experiencing Sleep Disturbances Due To The Impact Of Menopause

SleepDrops® International Limited2 个研究点分布在 1 个国家目标入组 36 人开始时间: 2025年10月6日最近更新: 2025年10月8日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 36
试验地点: 2
主要终点: Improvement in TST (total sleep time) from baseline

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigational treatment will be administered for a planned duration of 06 weeks. If the Investigator determines that continued use of the product may offer further benefit to the participant, treatment may be extended beyond 06 weeks at the Investigator’s discretion, based on clinical judgment and participant response. Treatment will be discontinued in the event of withdrawal of consent or if any adverse effect occurs that warrants discontinuation..

*Visit 1 is the day of signing the consent. Enrollment / screening / Baseline is conducted for the first 02 weeks and then treatment will start if patient still meets the criteria.

研究设计

研究类型: Interventional
分配方式: Na
盲法: Participant Blinded

入排标准

年龄范围: 30.00 Year(s) 至 50.00 Year(s)（—）
性别: Female

入选标准

•The person who met ICSD-3 insomnia criteria met and determined through CleverSleep SAS tool Participants who are having moderate to severe insomnia Patient must present with normal readings when tested for LFT and eGFR Creatinine levels and Blood Pressure Willing to take CleverSleep Products for the entire duration of the study Experiencing Hot flushes as noted in question 1 on the MISS with an impact and symptom score of 4 or greater Experiencing Night Sweats as noted in question 2 on the MISS with an impact and symptom score of 4 or greater Experiencing Sleep disturbances as noted in question 3 on the MISS with an impact and symptom score of 4 or greater Experiencing an average Pain score of 4 or greater on the CleverlSleep Adapted Numeric Pain Scale Experiencing Pain as noted in question 10 on the MISS with an impact and symptom score of 4 or greater Participants who are willing to complete all surveys Participants who are willing to give samples for safety testing.

排除标准

•Any other sleep disorders Excessive daytime sleepiness of unknown or untreated cause Parasomnias (e.g., sleepwalking, night terrors) and sleep-related movement disorders such as restless legs syndrome (RLS) Use of prescription sleep medications within the last 30 days Use of medications included on the exclusion checklist provided (Annexure VIII) No psychiatric (including depression and anxiety) or neurological conditions Pregnant or breastfeeding women will be excluded History of alcohol/substance abuse Shift workers Smokers Major stress event in past 03 months Deprivation index-ensuring socioeconomic consistency and in employment Participants with a child under the age of 5 in the household will be excluded.