The Ability of Songha Night ® to Improve Sleep in Patients With Mild to Moderate Sleep Disturbances

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Sleep Initiation and Maintenance Disorders

Treatments: Drug: Placebo; Drug: Songha Night ®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183714

582.1

Details and patient eligibility

About

To evaluate the effect of Songha Night ® on insomnia, anxiety and quality of life compared to placebo in patients with mild to moderate insomnia.

Enrollment: 146 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Psychophysiologic insomnia
• Severity: mild to moderate
• Duration: subacute to chronic
• Subjects age > 18 and < 65, men or women
• Subject had to give written informed consent

Exclusion criteria

• Regular use of psycho-active drugs
• Work in shifts
• Use of psychoactive drugs during the past 30 days
• Any treatment that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, psychiatric disorder, myasthenia gravis, delirious state, etc.)
• known hypersensitivity to any of the ingredients of the study drug
• Pregnancy, lactation, women of childbearing potential not using an established contraceptive
• Drug and alcohol abuse
• Participation in another trial within the past 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups, including a placebo group

Songha Night ®

Experimental group

Treatment:

Drug: Songha Night ®

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo