A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome (PLDS)
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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: NCT04141969 |
Recruitment Status :
Completed
First Posted : October 28, 2019
Last Update Posted : April 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Post-Lyme Disease Syndrome (PLDS) | Dietary Supplement: RLP Other: Placebo | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Novel Nutraceutical to Combat Post-Lyme Disease Syndrome |
Actual Study Start Date : | November 29, 2019 |
Actual Primary Completion Date : | December 31, 2020 |
Actual Study Completion Date : | March 28, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: RLP
ReaLife+
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Dietary Supplement: RLP
RLP nutraceutical |
Placebo Comparator: Inert
Inert brown powder to look similar to RLP
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Other: Placebo
Inert brown powder |
No Intervention: Control
Not given RLP or the placebo
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- PROMIS Global-10 [ Time Frame: 6 months ]PROMIS Global-10; Self reported level changes as measured by the Patient-Reported Outcomes Measurement Information System Global-10 .
- IHT Blood Test Assessment [ Time Frame: 6 months ]Outcome measure of "positive" or "negative" for antibodies; IgG P93 Ab. IgG P66 Ab. IgG P58 Ab. IgG P45 Ab. IgG P41 Ab. IgG P39 Ab. IgG P30 Ab. IgG P28 Ab. IgG P23 Ab. IgG P18 Ab.

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Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- Must be able to swallow a mixed powder drink.
Exclusion Criteria:
1 .Non Positive Western Blot test.
2. Positive Western Blot test where the individual has not been treated with antibiotics.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141969
United States, Utah | |
Optimal Health Research | |
Salt Lake City, Utah, United States, 84117 |
Principal Investigator: | Dr Osguthorpe, ND | Optimal Health Research |
Responsible Party: | Optimal Health Research |
ClinicalTrials.gov Identifier: | NCT04141969 |
Other Study ID Numbers: |
RLP10242019 |
First Posted: | October 28, 2019 Key Record Dates |
Last Update Posted: | April 12, 2021 |
Last Verified: | January 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lyme |
Lyme Disease Post-Lyme Disease Syndrome Syndrome Disease Pathologic Processes Gram-Negative Bacterial Infections Bacterial Infections |
Bacterial Infections and Mycoses Infections Borrelia Infections Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases |