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Novel Formulation for Sleep Among People With Poor Sleep Quality

NCT05609890 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-08-04

No results posted yet for this study

Summary

Sleep disorders are highly prevalent all around the world and have a strong negative impact on quality of life (QoL). In Colombia, up to 60% of adults report any sleep disturbance and more than 45% have required medical assistance for this. There is abundant anecdotal and scientific evidence supporting the efficacy and safety of several plant extracts on sleep quality. In this context, the development of safe and effective natural products may have a positive impact on sleep and general QoL.

Conditions

  • Sleep
  • Sleep Disorder
  • Insomnia
  • Quality of Life
  • Poor Quality Sleep

Interventions

DIETARY_SUPPLEMENT

Supplement

Supplement: a mixture of saffron, tea extract, lemon balm and valerian. Dose: The participant will take one sachet every day, one hour before going to bed, for six weeks.

OTHER

Placebo

Placebo sachet Dose: The participant will take one sachet everyday, one hour before going to bed, for six weeks.

Sponsors & Collaborators

  • Team Foods Colombia S.A.

    collaborator INDUSTRY

  • Carlos O Mendivil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2023-04-26
Completion
2023-07-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609890 on ClinicalTrials.gov