NCT02183714

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1998

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1998

Completed
15.6 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

7 months

First QC Date

July 7, 2014

Last Update Submit

July 7, 2014

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

  • Change in sleep quality on a 100 mm visual analogue scale (VAS)

    baseline, after 2 and 4 weeks of treatment, 1 week after end of treatment

Secondary Outcomes (9)

  • Feeling refreshed score (six point rating scale)

    up to week 5

  • Ability to concentrate and perform well score (six point rating scale)

    up to week 5

  • Night-time total sleeping time

    up to week 5

  • Difficulty in falling asleep (five point rating scale)

    up to week 5

  • Number of awakenings during the night

    up to week 5

  • +4 more secondary outcomes

Study Arms (2)

Songha Night ®

EXPERIMENTAL
Drug: Songha Night ®

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Songha Night ®DRUG
Songha Night ®
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 8, 2014

Study Start

May 1, 1998

Primary Completion

December 1, 1998

Last Updated

July 8, 2014

Record last verified: 2014-07