Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium glycinate, Melatonin.
- Who it may be relevant to
- Registry conditions: Primary Insomnia. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Magnesium glycinate
Tab Magnesium glycinate 500mg will be given to one group for treatment of primary insomnia - Drug Melatonin
Tab Melatonin 10mg will be given to the other group for treatment of primary insomnia
Primary outcome measures
- Insomnia Severity Index (ISI) [Time frame: 4 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- CMH Kharian Medical College — Kharan
Identifiers
NCT: NCT06996171 · CKMC/IERB/AC-00224