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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04381793
Other study ID # PAN study 2019-10
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2019
Est. completion date July 4, 2020

Study information

Verified date February 2020
Source Practitioners Alliance Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date July 4, 2020
Est. primary completion date July 4, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 -

Study Design


Intervention

Dietary Supplement:
Recovery Factors
Porcine serum amino acid/peptide

Locations

Country Name City State
United States Jacob Teitelbaum MD Kailua Hawaii

Sponsors (1)

Lead Sponsor Collaborator
Practitioners Alliance Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary VAS Composite VAS (1-10) for Fatigue, Pain, Cognition, Sleep and overall well-being 6 weeks
Secondary antibody titres Total IgG and IgG 1-4 subsets 10 weeks
Secondary FIQ-R Fibromyalgia severity scale 6 weeks
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