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ISRCTN
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ISRCTN05731670
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ClinicalTrials.gov identifier
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Public title
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Syalogram in chronic fatigue syndrome
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Scientific title
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The syalogram: utility of a biochemical test for evaluation of salival alterations in chronic fatigue syndrome (CFS) and other related diseases
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Acronym
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Syalogram in CFS
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Serial number at source
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218/09
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Study hypothesis
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In chronic fatigue syndrome (CFS) salivary disorders are common. Xerostomia, burning mouth, gingivitis and mucosal ulcers are clinical presentations of salivary disorders.
Hypothesis:
We have developed an easy biochemical salivary test to determine pH, sodium (Na), potassium (K), proteins and cortisol concentrations, and the volume/minute of salivary secretion: the syalogram. We want to standardise it as a reliable method of testing salivary function. We want to find the alterations of the salivary function in patients with chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME), fibromyalgia (FM), Sjögren's syndrome and other related diseases.
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Lay summary
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Ethics approval
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Center for Applied Medical Research (CIMA) Clinic committee gave approval (ref: 23/2009)
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Study design
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Interventional non-randomised non-controlled clinical descriptive study
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Chronic fatigue syndrome/fibromyalgia/Sjögren's syndrome
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Participants - inclusion criteria
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1. Chronic fatigue syndrome (CFS), fibromyalgia (FM), Sjögren's syndrome or sicca syndrome
2. One of the following symptoms: xerostomia, burning mouth, mucosal ulcers
3. No age range, either sex
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/05/2009
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Anticipated end date
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30/08/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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50
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Interventions
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Collection of one sample of saliva for biochemical test and one sample for volume/minute determination. There is no follow-up and the duration of each test is under one minute.
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Primary outcome measure(s)
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Concentration of Na, K, cortisol, proteins, pH.
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Secondary outcome measure(s)
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Volume/minute of saliva secreted.
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Sources of funding
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Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Fundacion para la Fibromialgia y el Síndrome de Fatiga Crónica) (Spain)
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Trial website
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http://www.institutferran.org/investigacion.htm
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Publications
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Contact name
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Dr
Antoni
Fernandez Sola
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Address
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Paseo Manuel Girona, 23
Edificio San Odon
Clinica CIMA
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City/town
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Barcelona
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Zip/Postcode
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08034
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Country
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Spain
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Email
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antoni.fernandez@cimaclinic.com
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Sponsor
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Foundation for Fibromyalgia and Chronic Fatigue Syndrome (Spain)
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Address
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Paseo Manuel Girona, 23
2-planta
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City/town
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Barcelona
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Zip/Postcode
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08034
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Country
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Spain
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Email
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info@fundacionfatiga.org
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Sponsor website:
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http://www.fundacionfatiga.org
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Date applied
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09/04/2009
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Last edited
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20/04/2009
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Date ISRCTN assigned
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20/04/2009
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