Evaluation of a Food Supplement on Sleep Quality

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

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy on sleep quality of a food supplement.

Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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cyclamax

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteer aged between 25 to 65 years
* Patient diagnosed for primary Insomnia (threshold for inclusion: 10 on the ISI scale)
* Healthy volunteer without diurnal sleep (total score for inclusion must be less than 10 on the Epworth scale)
* Patient affiliated to the French Social Security
* Patient who gave written informed consent

Exclusion Criteria

* Secondary insomnia
* History of severe psychiatric disorder, assessed by the MINI test
* Resistance to Hypnotic drugs
* Anxiety, depression, suicide, detected by the Beck Depression Inventory
* Acute Pathology during the precedent three years
* Breast feeding and pregnancy women
* Non compliant volunteer
* Hypersensibility to treatment composant

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Catherine Cornu, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center

Locations

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Clinical Research Center- Hopital Cardiologique

Lyon, , France

Site Status

Countries

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France

References

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Cornu C, Remontet L, Noel-Baron F, Nicolas A, Feugier-Favier N, Roy P, Claustrat B, Saadatian-Elahi M, Kassai B. A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial. BMC Complement Altern Med. 2010 Jun 22;10:29. doi: 10.1186/1472-6882-10-29.

Reference Type DERIVED

PMID: 20569455 (View on PubMed)

Other Identifiers

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DGS2006/0492

Identifier Type: -

Identifier Source: org_study_id