Condition category
Nervous System Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.W.M. van der Meer

ORCID ID

Contact details

University Medical Center St. Radboud
Department Internal Medicine
Expert Center Chronic Fatigue
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3618819
j.vandermeer@aig.umcn.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR167

Study information

Scientific title

Acronym

Study hypothesis

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.

Ethics approval

Received from local medical ethics committees

Study design

Randomised double blind placebo-controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic fatigue syndrome

Intervention

14 weeks acclydine combined with amino-acids.

Intervention type

Drug

Phase

Not Applicable

Drug names

Acclydine

Primary outcome measures

1. Fatigue-severity measured with CIS-fatigue
2. Functional impairment measured with Sickness Impact Profile
3. CDC-symptoms

Secondary outcome measures

1. Activity level measured with actometer
2. IGF-BP3-IGF-1 ratio

Overall trial start date

22/10/2002

Overall trial end date

01/10/2005

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

22/10/2002

Recruitment end date

01/10/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center St. Radboud
Nijmegen
6500 HB
Netherlands

Sponsor information

Organisation

University Medical Centre Nijmegen (Netherlands)

Sponsor details

P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 361 1111
info@ozi.umcn.nl

Sponsor type

Hospital/treatment centre

Website

http://www.umcn.nl/homepage

Funders

Funder type

Industry

Funder name

Optipharma BV (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17525791

Publication citations

  1. Results

    The GK, Bleijenberg G, van der Meer JW, The effect of acclydine in chronic fatigue syndrome: a randomized controlled trial., PLoS Clin Trials, 2007, 2, 5, e19, doi: 10.1371/journal.pctr.0020019.

Additional files

Editorial Notes