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Clinical Trials/EUCTR2006-005103-33-FR
EUCTR2006-005103-33-FR
Active, not recruiting
Not Applicable

Study of sleep characteristics and parameters in patients suffering from minors sleep disorders treated by the homeopathic medicinal product Somnidoron®, oral drops, solution. - Somnilog

aboratoires WELEDA0 sitesNovember 7, 2006
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ConditionsMinors sleep disordersMedDRA version: 8.1Level: LLTClassification code 10040984Term: Sleep disorder
DrugsSomnidoron, oral drops, solution (bottle of 30ml)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Minors sleep disorders
Sponsor
aboratoires WELEDA
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 7, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
aboratoires WELEDA

Eligibility Criteria

Inclusion Criteria

  • •Anyone consulting a physician taking part in the study for a minor sleep disorder:
  • •\- Adult aged between 18 and 70 years
  • •\- With light to moderate intensity minor sleep disorder, confirmed by Spiegel questionnaire (score \= 15\).
  • •\- Men or women using efficient contraceptive methods or post\-menopausal women
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •\- Secondary insomnia
  • •\- Serious organic affection
  • •\- Psychosis being able to appear by sleep disorders
  • •\- Contra indication (Summary of product Characteristics)
  • •\- Patient treated for sleep disorders
  • •\- Patient trated by corticoid or beta\-blocker medication
  • •\- Worker having a night shift
  • •\- Deficient knowledge or understanding of french language to complete correctly the self assessment questionnaire.
  • •\- Participation in another clinical trial
  • •\- Pregnant woman or nursing mother

Outcomes

Primary Outcomes

Not specified

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