A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Study Purpose

This study will determine the effectiveness of a nutraceutical in treating the lingering effects of Lyme Disease after antibiotic treatment.

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	12 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. A positive two-test methodology using a sensitive enzyme immunoassay (EIA) or immunofluorescence assay as a first test, followed by a western immunoblot assay for specimens yielding positive or equivocal results for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment. 2. Must be able to swallow a mixed powder drink.

Exclusion Criteria:

1 .Non Positive Western Blot test. 2. Positive Western Blot test where the individual has not been treated with antibiotics. -

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.	NCT04141969
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.	Phase 2/Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Optimal Health Research
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Dr Osguthorpe, ND
Principal Investigator Affiliation	Optimal Health Research
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Post-Lyme Disease Syndrome (PLDS)

Additional Details

A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome will be evaluated during a double blind, placebo controlled study. This study is an expansion of RLP042019 NCT04078841 Treating Post-Lyme Disease Syndrome With Acetogenins

Arms & Interventions

Arms

Active Comparator: RLP

ReaLife+

Placebo Comparator: Inert

Inert brown powder to look similar to RLP

No Intervention: Control

Not given RLP or the placebo

Interventions

Dietary Supplement: - RLP

RLP nutraceutical

Other: - Placebo

Inert brown powder

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.

Optimal Health Research, Salt Lake City, Utah

Status

Address

Optimal Health Research

Salt Lake City, Utah, 84117

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