The Effects of Melatonin in Sleep Disorders of Sarcoidosis Patients

Evaluating the Efficacy of Melatonin in Sleep Disorders of Sarcoidosis Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151227025726N25

Enrollment

100

Registered

2021-05-19

Start date

2021-06-22

Completion date

Unknown

Last updated

2021-05-26

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

Conditions

Pulmonary Sarcoidosis. Sarcoidosis of lung

Interventions

Intervention 1: Intervention group: Patients in the intervention group receive melatonin 3 mg for Razak pharmaceutical company, one hour before sleep for one month. Intervention 2: Control group: Pat

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with age above 18 years with pulmonary sarcoidosis and sleep-related disorders (Pittsburgh Sleep Quality Index equal or greater than 5) that refer to the Sarcoidosis Clinic of Masih Daneshvari Hospital.

Exclusion criteria

Exclusion criteria: Pregnancy Breastfeeding Neurological disease (stroke, epilepsy, tumor, previously neurologic manipulation) Use of any sedative or hypnotic drugs (anti histamine drugs, benzodiazepines) Use of stimulant drugs Allergy to melatonin or formulation components Having parasomnia Shift work sleep disorder Fluvoxamine consumption

Design outcomes

Primary

Measure	Time frame
The assessment of sleep quality. Timepoint: The assessment of sleep quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of PSQI and GSDS questionnaire scores.;The assessment of daytime sleepiness. Timepoint: The assessment of daytime sleepiness at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of ESS questionnaire score.;The assessment of fatigue status. Timepoint: The assessment of fatigue status at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of FAS and PROMIS questionnaire scores.;The assessment of life quality. Timepoint: The assessment of life quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of SF-12 questionnaire score.	—

Measure

Time frame

The assessment of sleep quality. Timepoint: The assessment of sleep quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of PSQI and GSDS questionnaire scores.;The assessment of daytime sleepiness. Timepoint: The assessment of daytime sleepiness at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of ESS questionnaire score.;The assessment of fatigue status. Timepoint: The assessment of fatigue status at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of FAS and PROMIS questionnaire scores.;The assessment of life quality. Timepoint: The assessment of life quality at initiation of study and 3 month after melatonin consumption. Method of measurement: With the measurement of SF-12 questionnaire score.

—

Secondary

Measure	Time frame
The assessment of pulmonary function. Timepoint: The assessment of pulmonary function at initiation of study and 3 month after melatonin consumption. Method of measurement: With the spirometry method.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFaezeh Feizabadi

Shahid Beheshti University of Medical Sciences

faezehfe@gmail.com+98 21 8820 0118

Outcome results

None listed

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