FibromyalgiaNCT04381793
Treatment of CFS & 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
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 4 Jul 2020
- 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 ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)
Who cannot join
- Pregnant Clotting disorders
- -
Trial locations and contacts
1 site in 1 country.
About this study
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome
Read the detailed description
Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum
- 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
Porcine serum amino acid/peptide
| Study group | Role | What they receive |
|---|---|---|
| Assessing clinical efficacy | Experimental | Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects Receives: Dietary Supplement: Recovery Factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
Measured: 6 weeks
Secondary outcomes (2)
antibody titres
Total IgG and IgG 1-4 subsets
Measured: 10 weeks
FIQ-R
Fibromyalgia severity scale
Measured: 6 weeks
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 start20 May 2019
- Primary completion4 Jul 2020
- Study completion4 Jul 2020
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 to assess efficacy and antibody effects
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Practitioners Alliance Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaetano Morello, ND, Principal investigator, Woman's Hospital in Vancouver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381793
- Sponsor's protocol ID
- PAN study 2019-10
- Status last verified
- Feb 2020
- First submitted
- 6 May 2020
- Last updated
- 19 Oct 2020
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of CFS & Fibromyalgia With Recovery Factors
- ClinicalTrials.gov ID
- NCT04381793
- Acronym / sponsor ID
- PAN study 2019-10
- Conditions
- Fibromyalgia, Chronic Fatigue Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Practitioners Alliance NetworkUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 4 Jul 2020 (actual)
- Study completion
- 4 Jul 2020 (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.
The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome
Detailed description
Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. Subjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum
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 to assess efficacy and antibody effects
| Arm | Type | Receives |
|---|---|---|
| Assessing clinical efficacy | Experimental | Dietary Supplement: Recovery FactorsSubjects will receive four tablets twice a day (three times a day for five day loading dose), taking the treatment for 5 - 6 weeks. The treatment is a unique nutritional peptide mix derived from porcine serum. Pre-and post FIQ-R and VA symptom score will be assessed as well as overall well-being. In a subgroup, pre-and post antibody levels will also be checked. Phase 1 will be a group of 60 subjects |
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 ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)
Key exclusion criteria (2 listed)
- Pregnant Clotting disorders
- -
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 FactorsPorcine serum amino acid/peptide | Dietary supplement | Assessing clinical efficacy |
Primary outcome
VAS
Time frame: 6 weeks
Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being
2 secondary outcomes
antibody titres
Time frame: 10 weeks
FIQ-R
Time frame: 6 weeks
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 19 Oct 2020.
- 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.
Gaetano Morello, ND principal investigator
Woman's Hospital in Vancouver
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 19 Oct 2020. 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?
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 19 Oct 2020.