Trial document




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  DRKS00006976

Trial Description

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Title

Data collection RELIEF -
Data collection with a herbal combination product as a dietary-supportive measure for alcohol detoxification

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Trial Acronym

RELIEF

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The "Eusano formulation" is a supplement and can be used during an alcohol detoxification therapy to improve well-being.

The Eusano formulation is a herbal combination product and can be used in order to support the reduction or discontinuing of alcohol consumption.

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Brief Summary in Scientific Language

The "Eusano formulation" is a dietary-supportive supplement and can be used during an alcohol detoxification therapy to improve well-being.
The Eusano formulation is a herbal combination product, consisting of 90 mg of cocoa extract (45% polyphenols, Theobroma cacao), 30 mg Passion flower extract (Passiflora incarnata), 15 mg of saffron extract (Crocus sativus), 165 mg of radish extract (Raphanus sativus L. var. Niger ) and 100 mg extract of black cumin (Nigella sativa L.).

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Organizational Data

  •   DRKS00006976
  •   2014/10/28
  •   [---]*
  •   no
  •   Approved
  •   014/1203, Freiburger Ethik-Kommission International
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Secondary IDs

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Health Condition or Problem studied

  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   Intake of Eusano formulation 3 capsules per day
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Knowledge about changes in well-being during an alcohol detoxification therapy by taking dietary-supportive supplement (Eusano formulation).
The results will be obtained by using a questionnaire (Bf-SR '), which will be filled out by the patient only 5 times during the detoxification therapy.

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Secondary Outcome

Not applicable

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/01/08
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

• Male and female patients over 18 years (no upper age limit), who are participating in an alcohol detoxification therapy and taking the dietary-supportive supplement (Eusano formulation)
• Pure alcohol dependence
• No known contraindications
• Written informed consent of the patient to the prospective collection, distribution, analysis of the data and for publication of the results.

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Exclusion Criteria

• Patients under 18 years
• Polytoxicomania
• Allergies to the various herbal ingredients of EUSANO formulation (food intolerance)
• Pregnancy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Eusano GmbH & Co. KG
    • Mr.  Dr.  Mathias  Schmidt 
    • Wartbergweg 15
    • 86874  Tussenhausen-Mattsies
    • Germany
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    • Eusano GmbH & Co. KG
    • Mr.  Dr.  Mathias  Schmidt 
    • Wartbergweg 15
    • 86874  Tussenhausen-Mattsies
    • Germany
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    • Institut Dr. Schauerte
    • Ms.  Gökcen  Alco 
    • Finkenstr. 7
    • 80333  München
    • Germany
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Sources of Monetary or Material Support

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    • Eusano GmbH & Co. KG
    • Mr.  Dr.  Mathias  Schmidt 
    • Wartbergweg 15
    • 86874  Tussenhausen-Mattsies
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/07/23
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.