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NCT Number: NCT06996171

Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia

Sleep is essential for our overall health and well-being, much like food and water. It plays a vital role in numerous bodily functions. Many studies have been conducted to determine the efficacy of melatonin congeners and Mg supplements in patients with insomnia separately. This study aims to compare the efficacy of melatonin and magnesium supplements in young adults with primary insomnia. Most insomnia studies focus on older adults or individuals with comorbidities. Targeting otherwise healthy young adults brings age-specific relevance and novel insight.

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Key information

Conditions

Primary Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMH Kharian Medical College

Kharan, Punjab Province, 50070, Pakistan

Location status: Recruiting

Location contact

Mushayada Irshad, MBBS, Mphil

CONTACT

[email protected]

+92537532239

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-40 years
  • Gender: Male and Females (Non-pregnant & Non lactating)
  • Diagnosed cases of primary insomnia according to following criteria:
  • Difficulty falling asleep, staying asleep or nonrestorative sleep
  • This difficulty is present despite adequate opportunity & circumstance to sleep
  • This impairment in sleep is associated with daytime impairment or distress
  • This sleep difficulty occurs at least 3 times per week and has been a problem for at least 1 month

Exclusion criteria

  • Insomnia due to a known underlying cause
  • Any psychiatric illness
  • Active use of sedative hypnotics

Treatment and study plan

Magnesium glycinate

Drug

Tab Magnesium glycinate 500mg will be given to one group for treatment of primary insomnia

Melatonin

Drug

Tab Melatonin 10mg will be given to the other group for treatment of primary insomnia

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 4 weeks

    ISI is a 7-item questionnaire used to determine the severity of insomnia.

Study contacts

Contact information is provided by the study sponsor or research team.

Mushayada Irshad, MBBS, MPhil Pharmacology

CONTACT

[email protected]

+923237088421

Usman Nawaz, MBBS, MPhil, PhD Pharmacology

CONTACT

[email protected]

+923335641664

Sponsors and collaborators

Lead sponsor

CMH Kharian Medical College

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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