This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.
After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
82
Variation in PSQI(Pittsburgh Sleep Quality Index)
Variation in PSQI before and immediately after the administration of the drug
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in RBDQ(The REM sleep Behavior Disorder screening Questionnaire)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in PDSS(The Parkinson's Disease Sleep Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in ESS(The Epworth Sleepiness Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in UPDRS(Unified Parkinson Disease Rating Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in H & Y Scale(Hoehn and Yahr Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in NMSS(Non-Motor Symptom assessment Scale)
Time frame: Baseline and immediately after administering the drug for 4 weeks
Variations in PDQ-39(The 39-Item Parkinson's Disease Questionnaire)
Time frame: Baseline and immediately after administering the drug for 4 weeks
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