Treating Post-Lyme Disease Syndrome With Acetogenins

February 8, 2020 updated by: Optimal Health Research

Using ReaLife+ to Treat Post-Lyme Disease Syndrome

To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS). After failure of antibiotic therapy to relive persistent symptoms of Lyme Disease, the use of Acetogenins to elevate Post-Lyme Disease Syndrome.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Optimal Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.

  2. Must be able to swallow and mixed powder drink.

    -

Exclusion Criteria:

  1. Non Positive Western Blot test.

  2. Positive Western Blot test where the indivual has not been treated with antibiotics.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: ReaLife+ (RLP)
Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
Dietary supplement: ReaLife+ (RLP)
RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
Placebo Comparator: Inert Brown Powder

Brown powder

Inert brown powder to look similar to RLP
Other: Inert Brown powder
Brown powder Inert brown powder to look similar to RLP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood test
Time Frame: 3 months
Western Blot showing "negative"
3 months
PROMIS Fatigue Scale
Time Frame: 3 months
Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Optimal Health Research

Investigators

  • Study Chair: Dr Jeppsen, MD, IRB Chair

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2019

Primary Completion (Actual)

November 14, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

August 31, 2019

First Submitted That Met QC Criteria

August 31, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 8, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RLP042019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-Lyme Disease Syndrome (PLDS)

Clinical Trials on ReaLife+ (RLP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe