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

NCT06996171 | Recruiting DMC

• 1 other identifier: CKMC/IERB/AC-00224
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

Primary Insomnia; Magnesium supplement; Melatonin congener

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

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

  4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive magnesium supplements for 4 weeks (Oral, Tablet, Dose 500mg/day at night)

Drug: Magnesium glycinate

Group B

ACTIVE COMPARATOR

Group B will receive melatonin congener for 4 weeks (Oral, Tablet, Dose 10mg/day at night)

Drug: Melatonin

Interventions

Magnesium glycinate DRUG

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

Group A

Melatonin DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CMH Kharian Medical College: lead

Study Sites (1)

CMH Kharian Medical College

Kharan, Punjab Province, 50070, Pakistan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

magnesium diglycinate; Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Mushayada Irshad, MBBS, MPhil Pharmacology

CONTACT

+923237088421; mishy2360@gmail.com

Usman Nawaz, MBBS, MPhil, PhD Pharmacology

CONTACT

+923335641664; drusmannawaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: May 5, 2025
• Primary Completion: August 31, 2025
• Study Completion: October 30, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

PA (1)