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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Brief Summary

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

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Detailed Description

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Conditions

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Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Songha Night ®

Group Type EXPERIMENTAL

Songha Night ®

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Songha Night ®

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No