Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Clever Sleep 1
Clever Sleep 2
Clever Sleep 3: 3 Capsules per day
2 ml per day
4 Capsules per day
Oral Dose
6 Weeks
Control Intervention1: Not Applicable: Not Applicable
Sponsors
SleepDrops International Limited
Spinos Life Science and Research Private limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in TST (total sleep time) from baseline Improvement in sleep latency (time to get to sleep) Decrease in night time awakenings Improvement in time to get back to sleep if woken Improvement in how alert 30 minutes after waking Pain reduction (using CS Adapted NPS and MISS Question 10 to establish a reduction in impact and scores) MISS Questionnaire Hot flushes/night sweats impact scores reduction (using MISS Questions 1 and 2) Insomnia improvement (using MISS Question 3) Improvement in Quality of Life and other menopausal symptoms (using MISS tool impact scores) Timepoint: Week 00 Week 02 Week 04 Week 06 week 08 | — |
Secondary
| Measure | Time frame |
|---|---|
| If any adverse events (AE) or abnormal biological markers occur during the study period with their associated incidence and severityTimepoint: Week 00 Week 02 Week 04 Week 06 week 08 | — |
Countries
India
Contacts
Public ContactDr Anbhazagan Ramaraju
Delta Diabetic Centre
Outcome results
None listed