Chronic Fatigue SyndromeimmunopropNCT01893619
Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome
An observational study of Chronic Fatigue Syndrome, run by New York CFS Association at 1 site in United States.
Trial summary
Observational study regarding the use of supplements in chronic fatigue syndrome patients Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Chronic Fatigue Syndrome
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection
Who may be able to join
- Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection
Who cannot join
- non inclusion in the above criteria
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Me/Cfs Center,860 Fifth Avenue
New York, New York, 10065
derek enlander, MD, 212-794-2000, denlander@aol.com
derek enlander, md
About this study
Observational study regarding the use of supplements in chronic fatigue syndrome patients
Read the detailed description
Detailed questionnaire regarding the diagnosis of an onset of chronic fatigue syndrome and 100 patients. using Karnofsky scale before and after use of supplements patient scores are compared in a double blind trial.
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic fatigue syndrome, Karnofsky score, supplements
- Medical subject headings
- Fatigue Syndrome, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Karnovsky score comparison
Review of Karnofsky score over prior to diagnosis and subsequent to patients having taken supplements
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York CFS Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEREK enlander, Principal investigator, CFIDS RESEARCH FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01893619
- Sponsor's protocol ID
- immunoprop
- Acronym
- immunoprop
- Status last verified
- Jul 2013
- First submitted
- 2 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Research on Use of Immunoprop Supplement in Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT01893619
- Acronym / sponsor ID
- immunoprop / immunoprop
- Conditions
- Chronic Fatigue Syndrome
- Keywords
- Chronic fatigue syndrome, Karnofsky score, supplements
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New York CFS AssociationUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study regarding the use of supplements in chronic fatigue syndrome patients
Detailed description
Detailed questionnaire regarding the diagnosis of an onset of chronic fatigue syndrome and 100 patients. using Karnofsky scale before and after use of supplements patient scores are compared in a double blind trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection
Key inclusion criteria (1 listed)
- Fukuda criteria and Canadian consensus criteria will be the diagnosis criteria for patient selection
Key exclusion criteria (1 listed)
- non inclusion in the above criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Karnovsky score comparison
Time frame: Six months
Review of Karnofsky score over prior to diagnosis and subsequent to patients having taken supplements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2013.
Related trials for Chronic Fatigue Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEREK enlander principal investigator
CFIDS RESEARCH FOUNDATION
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome, run by New York CFS Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karnovsky score comparison (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2013.