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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21358

Enrollment

Registered

2005-09-01

Start date

2002-10-22

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic fatigue syndrome.

Interventions

14 weeks Acclydine combined with amino-acids.

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Lactating women; 3. Participation in CVS treatment programs; 4. Recent participation in other CVS treatment research; 5. Psychiatric co-morbidity.

Design outcomes

Primary

Measure	Time frame
1. Fatigue-severity measured with CIS-fatigue; 2. Functional impairment measured with Sickness Impact Profile; 3. CDC-symptoms.	—

Secondary

Measure	Time frame
1. Activity level measured with actometer; 2. IGF-BP3-IGF-1 ratio.	—

Contacts

Public ContactG.K.H. The

University Medical Center St. Radboud, Department Internal Medicine, Expert Center Chronic Fatigue, P.O. Box 9101

g.the@aig.umcn.nl+31 (0)24 3618819

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)