A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

Phase 3CompletedNCT04141969

Optimal Health Research100 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Post-Lyme Disease Syndrome (PLDS)

Interventions

RLPDIETARY_SUPPLEMENT

RLP nutraceutical

PlaceboOTHER

Inert brown powder

Eligibility

Sex: ALLMin age: 12 YearsMax age: 75 Years

Medical Language ↔ Plain English

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. \-

Locations (1)

Optimal Health Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

PROMIS Global-10

PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .

Time frame: 6 months

IHT Blood Test Assessment

Outcome measure of "positive" or "negative" for antibodies; IgG P93 Ab. IgG P66 Ab. IgG P58 Ab. IgG P45 Ab. IgG P41 Ab. IgG P39 Ab. IgG P30 Ab. IgG P28 Ab. IgG P23 Ab. IgG P18 Ab.

Time frame: 6 months

Data from ClinicalTrials.gov

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