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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2025-10-30

Brief Summary

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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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Detailed Description

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Conditions

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Primary Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

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

Group Type EXPERIMENTAL

Magnesium glycinate

Intervention Type DRUG

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

Group B

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

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DRUG

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

Interventions

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Magnesium glycinate

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

Intervention Type DRUG

Melatonin

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

Intervention Type DRUG

Eligibility Criteria

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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