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The effect of melatonin on sleep quality in patients with mild traumatic brain injury

The effect of melatonin on sleep quality in patients with mild traumatic brain injury

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220504054738N1
Enrollment
60
Registered
2023-03-08
Start date
2023-03-21
Completion date
Unknown
Last updated
2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild traumatic brain injury. Concussion

Interventions

Intervention 1: Intervention group: 3 mg melatonin tablet from Razek Pharmaceutical Company is prescribed at night (one hour before bedtime).If there is no proper response in the melatonin group, the

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Not having a proved sleep disorder History of mTBI during one past month Not having allergy to both if the drugs Not having hepatic failure Not having respiratory problems or apnea and not consuming opiates Not having cognitive disorders or dimentia Age between 18 to 60

Exclusion criteria

Exclusion criteria: Cessation of therapy Consuming other hypnotic drugs otherwise the ones ordered in this study Manifestation of adverse drug reaction during the study

Design outcomes

Primary

MeasureTime frame
Sleep quality. Timepoint: Measurements will be taken at the beginning of the study, after the end of treatment, one month and three months after treatment (4 times). Method of measurement: The instruments used to examine patients will be a researcher-made demographic questionnaire and the Petersburg Sleep Quality index Questionnaire and Epworth Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAidin Omidvar

Kashan University of Medical Sciences

mahshad.m125@gmail.com+98 31 5500 9999

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026