To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
146
Change in sleep quality on a 100 mm visual analogue scale (VAS)
Time frame: baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment
Feeling refreshed score (six point rating scale)
Time frame: up to week 5
Ability to concentrate and perform well score (six point rating scale)
Time frame: up to week 5
Night-time total sleeping time
Time frame: up to week 5
Difficulty in falling asleep (five point rating scale)
Time frame: up to week 5
Number of awakenings during the night
Time frame: up to week 5
Physical and mental health state by short form (SF-36) questionnaire
Time frame: up to week 5
Anxiety by State-Trait Anxiety Inventory
Time frame: up to week 5
Frequency of adverse events
Time frame: up to week 5
Global clinical impression on insomnia by short questionnaire
Time frame: up to week 5
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