Health Condition 1: G470- Insomnia
Conditions
Interventions
None listed
Sponsors
Carat Remedies PvtLtd Secret Alchemist
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects between 18 and 65 years. 2.Clinically diagnosed cases of Sleeplessness, defined as difficulty falling asleep, maintaining sleep, or early morning awakening, occurring at least 3 nights per week for the past 3 months, as per standard diagnostic criteria (e.g., DSM-5). 3.Baseline Pittsburgh Sleep Quality Index (PSQI) score of >=5, indicating poor sleep quality. 4.Willingness to sign informed consent and comply with all study procedures, including scheduled visits and use of the investigational product. 5. Generally healthy individuals or individuals with controlled medical conditions that do not interfere with the study objectives, as determined by the investigator.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women. 2.Participants with acute or uncontrolled medical conditions, such as severe respiratory conditions (e.g., COPD, asthma), cardiovascular diseases, or acute illnesses that could interfere with sleep or study participation. 3.Known history of significant psychiatric or neurological disorders, including major depression, bipolar disorder, schizophrenia, or sleep disorders associated with other mental or neurological conditions. 4. History of alcohol or drug abuse within the past 6 months, or current use of sedative-hypnotic medications. 5. History of systemic glucocorticoid consumption within the past 6 months. 6.Known allergies or hypersensitivity to any of the ingredients in the investigational product. 7. Participation in another clinical trial within the past 3 months. 8. Participants who, in the opinion of the investigator, are unlikely to adhere to the study treatment or protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the improvement in sleep quality from baseline to Day 45, measured using the Pittsburgh Sleep Quality Index (PSQI). A reduction in the PSQI score, which evaluates sleep latency, duration, efficiency, and disturbances, will indicate improved sleep quality.Timepoint: Day 1, Day 15, Day 30, and Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Skin Hydration and Health: The hydrating effects of Dream Body Cream will be evaluated using the Skin Hydration Scoring System (SHSS) over 45 days, with assessments at Baseline (Day 0), Days 15, 30, and 45. An improvement in SHSS scores is expected, indicating enhanced skin hydration and health. 2.User Satisfaction: Participant satisfaction and perceived effectiveness will be measured using the Visual Analogue Scale (VAS) at Baseline (Day 0), Days 15, 30, and 45. High satisfaction scores are expected, reflecting positive user experience and perceived product effectiveness. 3.Dermatological Safety: The incidence and severity of adverse events (AEs), including skin reactions, will be monitored at all visits (Days 0, 15, 30, and 45). Minimal to no adverse dermatological reactions are expected, confirming the safety of the cream for nightly use.Timepoint: Day 1, Day 15, Day 30, and Day 45 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed