Primary InsomniaNCT06996171
Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
A study testing Magnesium glycinate and Melatonin in people with Primary Insomnia, run by CMH Kharian Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Magnesium glycinate and Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Insomnia due to a known underlying cause
- Any psychiatric illness
- Active use of sedative hypnotics
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
CMH Kharian Medical College
Kharan, Punjab Province, 50070
Mushayada Irshad, MBBS, Mphil, +92537532239, info@ckmc.edu.pk
About this study
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
- Being tested
- Magnesium glycinate, Melatonin
- Keywords
- Primary Insomnia, Magnesium supplement, Melatonin congener
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium glycinateDrug
Tab Magnesium glycinate 500mg will be given to one group for treatment of primary insomnia
MelatoninDrug
Tab Melatonin 10mg will be given to the other group for treatment of primary insomnia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will receive magnesium supplements for 4 weeks (Oral, Tablet, Dose 500mg/day at night) Receives: Drug: Magnesium glycinate |
| Group B | Active comparator | Group B will receive melatonin congener for 4 weeks (Oral, Tablet, Dose 10mg/day at night) Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
ISI is a 7-item questionnaire used to determine the severity of insomnia.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start5 May 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMH Kharian Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mushayada Irshad, CMH Kharian Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06996171
- Sponsor's protocol ID
- CKMC/IERB/AC-00224
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It will be decided after participants' consent whether to share their IPD or not.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Magnesium Supplement and Melatonin Congener in Young Adults With Primary Insomnia
- ClinicalTrials.gov ID
- NCT06996171
- Acronym / sponsor ID
- CKMC/IERB/AC-00224
- Conditions
- Primary Insomnia
- Keywords
- Primary Insomnia, Magnesium supplement, Melatonin congener
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CMH Kharian Medical CollegeOther government
- Study start
- 5 May 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Magnesium glycinateGroup A will receive magnesium supplements for 4 weeks (Oral, Tablet, Dose 500mg/day at night) |
| Group B | Active comparator | Drug: MelatoninGroup B will receive melatonin congener for 4 weeks (Oral, Tablet, Dose 10mg/day at night) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-40 years
- Gender: Male and Females (Non-pregnant \& Non lactating)
- Diagnosed cases of primary insomnia according to following criteria:
Key exclusion criteria (3 listed)
- Insomnia due to a known underlying cause
- Any psychiatric illness
- Active use of sedative hypnotics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium glycinateTab Magnesium glycinate 500mg will be given to one group for treatment of primary insomnia | Drug | Group A |
| MelatoninTab Melatonin 10mg will be given to the other group for treatment of primary insomnia | Drug | Group B |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 4 weeks
ISI is a 7-item questionnaire used to determine the severity of insomnia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: Undecided. It will be decided after participants' consent whether to share their IPD or not.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium glycinate and Melatonin in people with Primary Insomnia, run by CMH Kharian Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mushayada Irshad, MBBS, MPhil Pharmacology (+923237088421, mishy2360@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.