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ISRCTN
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ISRCTN77271661
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ClinicalTrials.gov identifier
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Public title
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The effect of Acclydine on fatigue and functional status in patients with chronic fatigue syndrome
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR167
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Study hypothesis
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Acclydine is a plant sourced alkaloid which has effects on protein structure and metabolism. In particular it leads to the activation of the pituitary to increase release of growth hormone. The GH axis has been shown to be disturbed in chronic fatigue syndrome (CFS), so this alkaloid could be of benefit in CFS.
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Ethics approval
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Received from local medical ethics committees
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Study design
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Randomised double blind placebo-controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Chronic fatigue syndrome
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Participants - inclusion criteria
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1. Centre of Diseases Control (CDC)-diagnosed CFS-patients
2. Male and female patients aged 18 - 65 years
3. Elevated IGF-BP3/IGF-1 ratio
4. High-fatigue severity level
5. Substantial functional impairment
6. Written informed consent
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Participants - exclusion criteria
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1. Pregnancy
2. Lactating women
3. Participation in CVS treatment programs
4. Recent participation in other CVS treatment research
5. Psychiatric co-morbidity
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Anticipated start date
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22/10/2002
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Anticipated end date
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01/10/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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60
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Interventions
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14 weeks acclydine combined with amino-acids.
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Primary outcome measure(s)
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1. Fatigue-severity measured with CIS-fatigue
2. Functional impairment measured with Sickness Impact Profile
3. CDC-symptoms
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Secondary outcome measure(s)
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1. Activity level measured with actometer
2. IGF-BP3-IGF-1 ratio
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Sources of funding
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Optipharma BV (Netherlands)
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Trial website
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Publications
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2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17525791
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Contact name
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Dr
J.W.M.
van der Meer
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Address
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University Medical Center St. Radboud
Department Internal Medicine
Expert Center Chronic Fatigue
P.O. Box 9101
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Tel
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+31 (0)24 3618819
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Email
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j.vandermeer@aig.umcn.nl
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Sponsor
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University Medical Centre Nijmegen (Netherlands)
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Address
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P.O. Box 9101
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City/town
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Nijmegen
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Zip/Postcode
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6500 HB
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Country
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Netherlands
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Tel
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+31 (0)24 361 1111
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Email
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info@ozi.umcn.nl
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Sponsor website:
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http://www.umcn.nl/homepage
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Date applied
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20/12/2005
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Last edited
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13/05/2009
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Date ISRCTN assigned
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20/12/2005
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