A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome (PLDS)

Optimal Health Research

Status and phase: Completed; Phase 3; Phase 2

Conditions: Post-Lyme Disease Syndrome (PLDS)

Treatments: Dietary Supplement: RLP; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04141969

RLP10242019

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 patients

Sex: All

Ages: 12 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 3 patient groups, including a placebo group

RLP

Active Comparator group

Description:

ReaLife+

Treatment:

Dietary Supplement: RLP

Inert

Placebo Comparator group

Description:

Inert brown powder to look similar to RLP

Treatment:

Other: Placebo

Control

No Intervention group

Description:

Not given RLP or the placebo