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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078841
Other study ID # RLP042019
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date January 30, 2020

Study information

Verified date February 2020
Source Optimal Health Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date January 30, 2020
Est. primary completion date November 14, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Optimal Health Research Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Optimal Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood test Western Blot showing "negative" 3 months
Primary PROMIS Fatigue Scale Self reported fatigue level changes as measured by the Patient-Reported Outcomes Measurement Information System, Fatigue Scale. 3 months
See also
  Status Clinical Trial Phase
Completed NCT04141969 - A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome Phase 2/Phase 3