Treatment of CFS & Fibromyalgia With Recovery Factors

Study Purpose

The study will explore if Recovery Factors improve symptoms in fibromyalgia and chronic fatigue syndrome

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Meet ACR 2010 amended Fibromyalgia criteria or CDC CFS Criteria Overall well being score of 5 of less (on 0-10 VAS)

Exclusion Criteria:

Pregnant Clotting disorders -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04381793
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Practitioners Alliance Network
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Gaetano Morello, ND
Principal Investigator Affiliation Woman's Hospital in Vancouver
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Fibromyalgia, Chronic Fatigue Syndrome
Additional Details

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

Arms & Interventions

Arms

Experimental: Assessing clinical efficacy

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

Interventions

Dietary Supplement: - Recovery Factors

Porcine serum amino acid/peptide

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Jacob Teitelbaum MD, Kailua, Hawaii

Status

Recruiting

Address

Jacob Teitelbaum MD

Kailua, Hawaii, 96740

Site Contact

Jacob Teitelbaum

[email protected]

410-573-5389