Effects of Melatonin in Patients with Pulmonary Sarcoidosis

Phase 3

Recruiting

• Conditions: Pulmonary Sarcoidosis.; Sarcoidosis of lung; D86.0

• Registration Number: IRCT20151227025726N32
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

People over 18 years old
People with pulmonary sarcoidosis and concomitant sleep disorder (PSQI = 3)
Have signed the consent to participate in the study

Exclusion Criteria

Pregnancy
Breastfeeding
History of central nervous system disease (stroke, epilepsy, tumor, history of neurological manipulation)
Taking any sedative-hypnotic drugs (antihistamines, benzodiazepines)
Taking stimulant drugs
Allergy to melatonin or formulation components
Having parasomnias
Shift work sleep disorder
Taking fluvoxamine

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The amount of sleepiness during the day. Timepoint: At the start and end of the study. Method of measurement: ESS criteria.;Fatigue state. Timepoint: At the start and end of the study. Method of measurement: FAS and PROMIS criteria.;Quality of Life. Timepoint: At the start and end of the study. Method of measurement: SF-12 criteria.

Secondary Outcome Measures

Name	Time	Method
Pulmonary function of patients. Timepoint: At the start and end of the study. Method of measurement: Spirometry.