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The effect of Acclydine on fatigue and functional status in patients with chronic fatigue syndrome.


- candidate number1283
- NTR NumberNTR167
- ISRCTNISRCTN77271661
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR1-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of Acclydine on fatigue and functional status in patients with chronic fatigue syndrome.
- Scientific TitleThe effect of Acclydine on fatigue and functional status in patients with chronic fatigue syndrome.
- ACRONYMN/A
- hypothesisAcclydine 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 CFS, so this alkaloid could be of benefit in CFS.
- Healt Condition(s) or Problem(s) studiedChronic Fatigue Syndrome (CFS)
- Inclusion criteria1. CDC-diagnosed CFS-patients Male and female patients 18-65 years;
2. Elevated IGF-BP3/IGF-1 ratio;
3. High-fatigue severity level;
4. Substantial functional impairment;
5. Written informed consent.
- Exclusion criteria1. Pregnancy;
2. Lactating women;
3. Participation in CVS treatment programs;
4. Recent participation in other CVS treatment research;
5. Psychiatric co-morbidity.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-okt-2002
- planned closingdate1-okt-2005
- Target number of participants60
- Interventions14 weeks Acclydine combined with amino-acids.
- Primary outcome1. Fatigue-severity measured with CIS-fatigue;
2. Functional impairment measured with Sickness Impact Profile;
3. CDC-symptoms.
- Secondary outcome1. Activity level measured with actometer;
2. IGF-BP3-IGF-1 ratio.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESMD. G.K.H. The
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.W.M. Meer, van der
- Sponsor/Initiator University Medical Center St. Radboud
- Funding
(Source(s) of Monetary or Material Support)
Optipharma BV
- PublicationsPLoS Clin Trials. 2007 May 18;2(5):e19.
- Brief summaryAcclydine 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 CFS, so this alkaloid could be of benefit in CFS.
During a 14-weeks placebo-controlled trial, the efficacy of Acclydine combined with amino-acids will be assessed in CDC-diagnosed CFS-patients.
- Main changes (audit trail)
- RECORD23-aug-2005 - 11-sep-2008


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