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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A will receive magnesium supplements for 4 weeks (Oral, Tablet, Dose 500mg/day at night) |
|
| Group B | Active Comparator | Group B will receive melatonin congener for 4 weeks (Oral, Tablet, Dose 10mg/day at night) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnesium glycinate | Drug | Tab Magnesium glycinate 500mg will be given to one group for treatment of primary insomnia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | ISI is a 7-item questionnaire used to determine the severity of insomnia. | 4 weeks |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mushayada Irshad, MBBS, MPhil Pharmacology | Contact | +923237088421 | mishy2360@gmail.com | |
| Usman Nawaz, MBBS, MPhil, PhD Pharmacology | Contact | +923335641664 | drusmannawaz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMH Kharian Medical College | Recruiting | Kharan | Punjab Province | 50070 | Pakistan |
It will be decided after participants' consent whether to share their IPD or not.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C091418 | magnesium diglycinate |
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Melatonin | Drug | Tab Melatonin 10mg will be given to the other group for treatment of primary insomnia |
|
| D001523 |
| Mental Disorders |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |