The effect of Acclydine on fatigue and functional status in patients with chronic fatigue syndrome
| ISRCTN | ISRCTN77271661 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77271661 |
| Secondary identifying numbers | NTR167 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 13/05/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J.W.M. van der Meer
Scientific
Scientific
University Medical Center St. Radboud
Department Internal Medicine
Expert Center Chronic Fatigue
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3618819 |
|---|---|
| j.vandermeer@aig.umcn.nl |
Study information
| Study design | Randomised double blind placebo-controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Received from local medical ethics committees |
| Health condition(s) or problem(s) studied | Chronic fatigue syndrome |
| Intervention | 14 weeks acclydine combined with amino-acids. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Acclydine |
| Primary outcome measure | 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 study start date | 22/10/2002 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/10/2002 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center St. Radboud
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
University Medical Centre Nijmegen (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 361 1111 |
|---|---|
| info@ozi.umcn.nl | |
| Website | http://www.umcn.nl/homepage |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Industry
Optipharma BV (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 18/05/2007 | Yes | No |
