Evaluation of a Food Supplement on Sleep Quality (Cyclamax)

Persee Medica

Status: Completed

Conditions: Insomnia

Treatments: Drug: cyclamax

Study type: Interventional

Funder types: Industry

Identifiers

NCT00484497

DGS2006/0492

Details and patient eligibility

About

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

Enrollment: 105 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind