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 sites in 1 country36 target enrollmentStarted: October 6, 2025Last updated: October 8, 2025

Overview

Phase: Not Applicable
Status: Completed
Sponsor: SleepDrops® International Limited
Enrollment: 36
Locations: 2
Primary Endpoint: Improvement in TST (total sleep time) from baseline

Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

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.

Study Design

Study Type: Interventional
Allocation: Na
Masking: Participant Blinded

Eligibility Criteria

Ages: 30.00 Year(s) to 50.00 Year(s) (—)
Sex: Female

Inclusion Criteria

•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.

Exclusion Criteria

•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.