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

CMH Kharian Medical College

Status: Enrolling

Conditions: Primary Insomnia

Treatments: Drug: Magnesium glycinate; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT06996171

CKMC/IERB/AC-00224

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Magnesium glycinate

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Melatonin