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 CFS, so this…
ID
Bron
Verkorte titel
Aandoening
Chronic fatigue syndrome.
Ondersteuning
The Netherlands.
Handelsweg 5
6114 BR Susteren
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Fatigue-severity measured with CIS-fatigue;
<br>2. Functional impairment measured with Sickness Impact Profile;
<br>3. CDC-symptoms.
Achtergrond van het onderzoek
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 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.
Doel van het onderzoek
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 CFS, so this alkaloid could be of benefit in CFS.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
14 weeks Acclydine combined with amino-acids.
Algemeen / deelnemers
Expert Center Chronic Fatigue,
P.O. Box 9101
G.K.H. The
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3618819
g.the@aig.umcn.nl
Wetenschappers
Expert Center Chronic Fatigue,
P.O. Box 9101
G.K.H. The
Nijmegen 6500 HB
The Netherlands
+31 (0)24 3618819
g.the@aig.umcn.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnancy;
2. Lactating women;
3. Participation in CVS treatment programs;
4. Recent participation in other CVS treatment research;
5. Psychiatric co-morbidity.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL133 |
| NTR-old | NTR167 |
| Ander register | : N/A |
| ISRCTN | ISRCTN77271661 |