A Randomized, Open-Label Clinical Trial Comparing the Efficacy and Safety of Multi-Ingredient Sleep Gummy (Health Etc) versus Melatonin Monotherapy (Somelin 3mg) in Adults with Sleep Disorders: A 30-Day Comparative Study

This one-month randomized, open-label, comparative assessment aims to evaluate and compare the effects of melatonin-based sleep gummy supplements versus standard melatonin therapy on sleep quality in adults aged 40-70 experiencing sleep difficulties. Using validated public domain sleep assessment tools including the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI), the study will track changes in sleep parameters through scheduled assessments at baseline, mid-point (day 15), and study conclusion (day 30).

The two-arm, parallel-group design will randomize 150 participants who meet specific eligibility criteria into two treatment groups: Group A receiving standardized Health Etc sleep gummies containing multiple active ingredients including melatonin 3mg, and Group B receiving Somelin (Melatonin 3mg) tablets. Both groups will be followed through three clinic visits over 30 days.

Primary outcomes focus on comparative changes in PSQI scores between groups, while secondary outcomes include comparative insomnia severity reduction, quality of life improvements, and participant satisfaction. This protocol employs publicly available assessment tools without copyright restrictions and includes comprehensive eligibility screening to ensure appropriate participant selection.