Treatment of CFS & Fibromyalgia With Recovery Factors

NCT ID: NCT04381793

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2020-07-04

Brief Summary

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

Detailed Description

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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

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Fibromyalgia Chronic Fatigue Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open pilot study to assess efficacy and antibody effects
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Recovery Factors

Intervention Type DIETARY_SUPPLEMENT

Porcine serum amino acid/peptide

Interventions

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Recovery Factors

Porcine serum amino acid/peptide

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Practitioners Alliance Network

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gaetano Morello, ND

Role: PRINCIPAL_INVESTIGATOR

Woman's Hospital in Vancouver

Locations

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Jacob Teitelbaum MD

Kailua, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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PAN study 2019-10

Identifier Type: -

Identifier Source: org_study_id

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