A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome

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

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-29

Study Completion Date

2021-03-28

Brief Summary

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

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Detailed Description

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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

Conditions

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Post-Lyme Disease Syndrome (PLDS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RLP

ReaLife+

Group Type ACTIVE_COMPARATOR

RLP

Intervention Type DIETARY_SUPPLEMENT

RLP nutraceutical

Inert

Inert brown powder to look similar to RLP

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Inert brown powder

Control

Not given RLP or the placebo

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RLP

RLP nutraceutical

Intervention Type DIETARY_SUPPLEMENT

Placebo

Inert brown powder

Intervention Type OTHER

Eligibility Criteria

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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.