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

Not Applicable

Recruiting

• Conditions: Primary Insomnia
• Interventions: Drug: Magnesium glycinate; Drug: Melatonin

• Registration Number: NCT06996171
• Lead Sponsor: CMH Kharian Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-05
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-30
• Last Update Posted: 2025-05-30
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Magnesium glycinate	Group A will receive magnesium supplements for 4 weeks (Oral, Tablet, Dose 500mg/day at night)
Group B	Melatonin	Group B will receive melatonin congener for 4 weeks (Oral, Tablet, Dose 10mg/day at night)

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	4 weeks	ISI is a 7-item questionnaire used to determine the severity of insomnia.

Trial Locations

Locations (1)

CMH Kharian Medical College; 🇵🇰 Kharan, Punjab, Pakistan