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Dietary Supplement

Arm 1 before Cross Over for Sleep Quality

N/A
Waitlist Available
Research Sponsored by 4Life Research, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Summary

This trial is testing a special oral supplement to see if it can help people with sleep problems sleep better. Melatonin is considered a nutritional supplement and not regulated as a prescription medication in most countries; although safety data over extended periods are not available, studies suggest that it is relatively safe for most people.

Eligible Conditions
  • Sleep Quality
  • Sleep Hygiene

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index Score
Saliva Melatonin level changes
Secondary study objectives
Leeds Sleep Evaluation Questionnaire (LSEQ) Score
Sleep Efficiency
Sleep Onset Latency
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2 after Cross OverExperimental Treatment2 Interventions
In Arm 2, Supplement Group and Placebo Group cross over. After a 1-week washout period, and both group will take whatever product they did not take in Arm 2, for 2 week.
Group II: Arm 1 before Cross OverExperimental Treatment2 Interventions
Participants were randomized and divided into two groups: Supplement Group and Placebo Group. In this Arm 1, participants first go through a 1-week washout period, and then take either Supplement or Placebo as assigned for 2 week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Supplement
2021
N/A
~30
Placebo
1995
Completed Phase 3
~2670

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Who is running the clinical trial?

4Life Research, LLCLead Sponsor
5 Previous Clinical Trials
180 Total Patients Enrolled
~8 spots leftby Sep 2025
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