Back to resultsTreating Post-Lyme Disease Syndrome With Acetogenins
Primary Purpose
Post-Lyme Disease Syndrome (PLDS)
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ReaLife+ (RLP)
Inert Brown powder
Sponsored by
About this trial
This is an interventional treatment trial for Post-Lyme Disease Syndrome (PLDS)
Eligibility Criteria
Inclusion Criteria:
- A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
Must be able to swallow and mixed powder drink.
-
Exclusion Criteria:
- Non Positive Western Blot test.
Positive Western Blot test where the indivual has not been treated with antibiotics.
-
Sites / Locations
- Optimal Health Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
ReaLife+ (RLP)
Inert Brown Powder
Control
Arm Description
Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
Brown powder Inert brown powder to look similar to RLP
Control
Outcomes
Primary Outcome Measures
Blood test
Western Blot showing "negative"
PROMIS Fatigue Scale
Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT04078841
First Posted
August 31, 2019
Last Updated
February 8, 2020
Sponsor
Optimal Health Research
1. Study Identification
Unique Protocol Identification Number
NCT04078841
Brief Title
Treating Post-Lyme Disease Syndrome With Acetogenins
Official Title
Using ReaLife+ to Treat Post-Lyme Disease Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
November 14, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optimal Health Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To access the effectiveness of Acetogenins in treating Post-Lyme Disease Syndrome (PLDS).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Lyme Disease Syndrome (PLDS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReaLife+ (RLP)
Arm Type
Active Comparator
Arm Description
Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
Arm Title
Inert Brown Powder
Arm Type
Placebo Comparator
Arm Description
Brown powder
Inert brown powder to look similar to RLP
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Dietary Supplement
Intervention Name(s)
ReaLife+ (RLP)
Intervention Description
RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
Intervention Type
Other
Intervention Name(s)
Inert Brown powder
Intervention Description
Brown powder Inert brown powder to look similar to RLP
Primary Outcome Measure Information:
Title
Blood test
Description
Western Blot showing "negative"
Time Frame
3 months
Title
PROMIS Fatigue Scale
Description
Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A positive Western Blot for Lyme Disease that has been treated with antibiotics but the symptoms persist post treatment.
Must be able to swallow and mixed powder drink.
-
Exclusion Criteria:
Non Positive Western Blot test.
Positive Western Blot test where the indivual has not been treated with antibiotics.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Jeppsen, MD
Organizational Affiliation
IRB Chair
Official's Role
Study Chair
Facility Information:
Facility Name
Optimal Health Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treating Post-Lyme Disease Syndrome With Acetogenins
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