FibromyalgiaNCT04381780
Treatment of Fibromyalgia With Recovery Factors
A study testing Recovery Factors in people with Fibromyalgia and Chronic Fatigue Syndrome, run by Practitioners Alliance Network at 1 site in United States.
Trial summary
Treatment of Fibromyalgia and CFS with Recovery Factors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia, Chronic Fatigue Syndrome
- What is being tested?
- Recovery Factors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2020to 15 Jan 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS
Who cannot join
- Under 18 Pregnant Other severe complicating conditions
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
Treatment of Fibromyalgia and CFS with Recovery Factors
Read the detailed description
Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Being tested
- Recovery Factors
- Medical subject headings
- Fibromyalgia, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery FactorsDietary supplement
A unique porcine serum based polypeptide nutritional support
| Study group | Role | What they receive |
|---|---|---|
| Assessing clinical outcomes | Experimental | Nutritional support with Recovery Factors Receives: Dietary Supplement: Recovery Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite VAS
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
Measured: 6 weeks
Secondary outcomes (1)
FIQ-R
Fibromyalgia Impact Questionnaire
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start6 May 2020
- Primary completion1 Dec 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open pilot study
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Practitioners Alliance Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381780
- Sponsor's protocol ID
- PAN Study RF-2- 2020
- Status last verified
- Oct 2020
- First submitted
- 6 May 2020
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fibromyalgia With a Unique Polypeptide Nutritional Support
- ClinicalTrials.gov ID
- NCT04381780
- Acronym / sponsor ID
- PAN Study RF-2- 2020
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Practitioners Alliance NetworkUniversity, hospital or other
- Study start
- 6 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 11 May 2020 (actual)
- 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.
Treatment of Fibromyalgia and CFS with Recovery Factors
Detailed description
Use of a unique oral porcine peptide nutritional supplement in those meeting ACR 2010(amended) diagnostic criteria for Fibromyalgia or CDC Criteria for CFS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open pilot study
| Arm | Type | Receives |
|---|---|---|
| Assessing clinical outcomes | Experimental | Dietary Supplement: Recovery FactorsNutritional support with Recovery Factors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Meet the ACR 2010 Amended Fibromyalgia Diagnostic Criteria or CFS CDC criteria; Score 5 or less on Energy VAS
Key exclusion criteria (2 listed)
- Under 18 Pregnant Other severe complicating conditions
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recovery FactorsA unique porcine serum based polypeptide nutritional support | Dietary supplement | Assessing clinical outcomes |
Primary outcome
Composite VAS
Time frame: 6 weeks
Composite of VAS for Fatigue, sleep, cognition, pain and overall well being
1 secondary outcome
FIQ-R
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recovery Factors in people with Fibromyalgia and Chronic Fatigue Syndrome, run by Practitioners Alliance Network 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 2 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: finished, as of the sponsor's last update on 11 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite VAS (time frame: 6 weeks). 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 11 Oct 2021.