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Treating Post-Lyme Disease Syndrome With Acetogenins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04078841
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : February 11, 2020
Sponsor:
Information provided by (Responsible Party):
Optimal Health Research

Tracking Information
First Submitted Date  ICMJE August 31, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date February 11, 2020
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2019)
  • Blood test [ Time Frame: 3 months ]
    Western Blot showing "negative"
  • PROMIS Fatigue Scale [ Time Frame: 3 months ]
    Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2019)
  • Blood test [ Time Frame: 3 months ]
    Western Blot showing "negative"
  • PROMIS Fatigue Scale [ Time Frame: 3 months ]
    Self reported fatigue level changes as measured by the PROMIS Fatigue Scale.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treating Post-Lyme Disease Syndrome With Acetogenins
Official Title  ICMJE Using ReaLife+ to Treat Post-Lyme Disease Syndrome
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Post-Lyme Disease Syndrome (PLDS)
Intervention  ICMJE
  • Dietary Supplement: ReaLife+ (RLP)
    RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
  • Other: Inert Brown powder
    Brown powder Inert brown powder to look similar to RLP
Study Arms  ICMJE
  • Active Comparator: ReaLife+ (RLP)
    Dietary Supplement: ReaLife+ (RLP) RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids
    Intervention: Dietary Supplement: ReaLife+ (RLP)
  • Placebo Comparator: Inert Brown Powder

    Brown powder

    Inert brown powder to look similar to RLP

    Intervention: Other: Inert Brown powder
  • No Intervention: Control
    Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2019)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 30, 2020
Actual Primary Completion Date November 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04078841
Other Study ID Numbers  ICMJE RLP042019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Optimal Health Research
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Optimal Health Research
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Dr Jeppsen, MD IRB Chair
PRS Account Optimal Health Research
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP