The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
NCT ID: NCT05896878
Last Updated: 2025-03-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
1 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-07-10
Study Completion Date
2024-09-10
Brief Summary
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This is a research study to evaluate the effectiveness of daily supplementation with Root.Health, a plant-based dietary supplement, on reducing levels of 11 abnormal urine biomarkers associated with chronic pain. Biomarkers are molecules found in blood, tissues, or other body fluids (such as urine) that indicate normal or abnormal processes.
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Detailed Description
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This study aims to utilize pain-specific abnormal biomarkers to evaluate how daily supplementation with Root.Health, a plant-based dietary supplement, affects FPI urine screening scores in chronic opioid-consuming pain patients. Analyzing the effect of Root.Health supplementation on pain-specific biomarkers through changes in FPI scores may expand our understanding of the degree to which these biomarkers may correlate to the underlying biologic processes involved in chronic pain creation. While widespread identification of such abnormalities may prove to have profound impacts on the future prevention, diagnosis, and treatment of pain, this investigation only intends to evaluate the effect of Root.Health on patient's urine levels of abnormal biomarkers. A previous validation study of the urine assay used in FPI screening demonstrated that an estimated 86% of patients reporting pain have at least one abnormal pain-related biomarker. The plant-based ingredients of the Root.Health supplement have been previously studied in the context of biochemical abnormalities that drive pain development, and this study is designed to characterize the mechanism by which these ingredients act to maintain biochemical processes which normally attenuate pain. As such, this study is not intended to evaluate Root.Health's ability to diagnose, cure, mitigate, treat, or prevent any disease.
The compounds included Root.Health supplements were carefully selected based on methodological review of current scientific evidence describing their roles in supporting innate physiological processes that attenuate biochemical abnormalities driving pain development. The investigators hypothesize that the plant-based compounds included in Root.Health will reduce the levels of abnormal pain biomarkers in chronic pain patients, as measured by a change in FPI score from baseline, based on literature which suggests that these compounds may attenuate biochemical abnormalities involved in causative pain mechanisms by supporting specific markers of cellular health (i.e normal activity of inflammatory pathways, oxidative stress capacity, production of pain-related neurotransmitters, and micronutrient status).
This is an open-label, prospective, observational pilot study. The investigators will be using a single group assignment intervention model with one group of 20 subjects. The primary outcome of this study is to evaluate Foundational Pain Index scores following a 3-month daily supplementation course with Root.Health in an opiate-using chronic pain patient population at 1-month and 3-months. The secondary objective of this study is to evaluate if daily supplementation with Root.Health for a 3-month study period affects Brief Pain Inventory (BPI) Short Form and Oswestry Disability Index (ODI) scores and/or opiate consumption in this patient population. The total study duration for each eligible participant is 4 months, which will include 5 study points: initial in-person study visit, 1-week in-person follow up visit (where study participants will receive supplements), and 3 virtual follow up visits at 1-month, 2-months and 3-months.
The compounds included Root.Health supplements were carefully selected based on methodological review of current scientific evidence describing their roles in supporting innate physiological processes that attenuate biochemical abnormalities driving pain development. The investigators hypothesize that the plant-based compounds included in Root.Health will reduce the levels of abnormal pain biomarkers in chronic pain patients, as measured by a change in FPI score from baseline, based on literature which suggests that these compounds may attenuate biochemical abnormalities involved in causative pain mechanisms by supporting specific markers of cellular health (i.e normal activity of inflammatory pathways, oxidative stress capacity, production of pain-related neurotransmitters, and micronutrient status).
This is an open-label, prospective, observational pilot study. The investigators will be using a single group assignment intervention model with one group of 20 subjects. The primary outcome of this study is to evaluate Foundational Pain Index scores following a 3-month daily supplementation course with Root.Health in an opiate-using chronic pain patient population at 1-month and 3-months. The secondary objective of this study is to evaluate if daily supplementation with Root.Health for a 3-month study period affects Brief Pain Inventory (BPI) Short Form and Oswestry Disability Index (ODI) scores and/or opiate consumption in this patient population. The total study duration for each eligible participant is 4 months, which will include 5 study points: initial in-person study visit, 1-week in-person follow up visit (where study participants will receive supplements), and 3 virtual follow up visits at 1-month, 2-months and 3-months.
Conditions
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Pain, Chronic
Opioid Dependence
Opioid Use
Inflammation Chronic
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
This study is a prospective, open-label, non randomized evaluation of daily supplementation with Root.Health, a plant-based anti-inflammatory dietary supplement, on Foundation Pain Index (FPI) scores in a chronic opiate patient population. The daily supplement is offered without charge to study participants. All patients are counseled and consented per established protocol as per established IRB requirements. This study will enroll 20 total patients. The details of the study design, patient demographics, description of the intervention method, and statistical tests performed are described.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Daily Supplement Treatment
Following study recruitment and obtaining consent, participants will complete a baseline urine test. The FPI is a simple urine test from Ethos Laboratories that screens for 11 biomarkers that are more likely to contribute to symptoms of pain.
Group Type
EXPERIMENTAL
Root.Health Dietary Supplement
Intervention Type
DIETARY_SUPPLEMENT
The Root.Health supplement is composed of six plant-based compounds with established roles in supporting innate physiological processes which are implicated in pain: tetrohydrocurcumin, ergothioneine, dihydroberberine, trans-resveratrol, ginger root extract, and methylcobalamin. Participants will take the provided supplement twice per day for the entire study duration in addition to pain management treatment protocols the participants currently follow.
Interventions
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Root.Health Dietary Supplement
The Root.Health supplement is composed of six plant-based compounds with established roles in supporting innate physiological processes which are implicated in pain: tetrohydrocurcumin, ergothioneine, dihydroberberine, trans-resveratrol, ginger root extract, and methylcobalamin. Participants will take the provided supplement twice per day for the entire study duration in addition to pain management treatment protocols the participants currently follow.
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Participants must be 18 years of age or older
* At least two (2) or more symptoms of moderate or higher severity musculoskeletal pain for at least one year prior to study enrollment
* At least 3 months of opioid use for pain management at time of study enrollment
* At least two (2) or more symptoms of moderate or higher severity musculoskeletal pain for at least one year prior to study enrollment
* At least 3 months of opioid use for pain management at time of study enrollment
Exclusion Criteria
* under 18 years of age
* participants who are pregnant or breastfeeding at time of study recruitment
* participants who are pregnant or breastfeeding at time of study recruitment
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Ethos Research & Development
INDUSTRY
Sponsor Role
collaborator
Hudson Medical
OTHER
Sponsor Role
lead
Responsible Party
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Jonathann Kuo, MD
Principial Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jonathann Kuo, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Director, Hudson Medical
Locations
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Hudson Medical
New York, New York, United States
Site Status
Countries
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United States
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Other Identifiers
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BRANY #22-02-797-993
Identifier Type: -
Identifier Source: org_study_id
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RECRUITING
EARLY_PHASE1
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
NCT00605644
COMPLETED
PHASE2
Effects of a Range of Naltrexone Doses in Combination With Smoked Marijuana
NCT00403117
COMPLETED
PHASE2
Determining the Clinical Relevance of the Interaction Between Enzalutamide and the Opioid Morphine and the DOAC Edoxaban
NCT05339672
UNKNOWN
Enhancing Medication-based Analgesia in Humans- STUDY 2
NCT04036968
COMPLETED
PHASE2
Human Brain Adaptation to Chronic Pain and Its Effects on Opioid Use
NCT03248765
TERMINATED
Using Technology to Track Pain and Pain-related Outcomes
NCT04267588
RECRUITING
Attenuation of Pain in Men and Women
NCT01220414
COMPLETED
NA
Cessation of Long-term Opioid Therapy in Chronic Pain Patients
NCT02132221
TERMINATED
NA
Investigation of the Pharmacokinetic Profile of CBD
NCT05269706
COMPLETED
PHASE1
Study of the Characteristics of Chronic Pain in Patients With Addiction
NCT05976178
COMPLETED
A Double-blind Study of Controlled Release OROS Hydromorphone Compared to Placebo in Patients With Chronic Osteoarthritis (OA) Pain
NCT00631319
COMPLETED
PHASE3
To Assess the Rate and Extent of Absorption of Hydrocodone From 20 mg Hydrocodone Bitartrate Extended-Release Capsules
NCT02117141
COMPLETED
PHASE1
Dosing Intervals of Opioid Medication for Chronic Pain
NCT04132011
WITHDRAWN
PHASE4
Acute Pain Management in Patients on Opioid Replacement Therapy
NCT03933865
TERMINATED
PHASE1
Effect of Guanfacine on Opioid-induced Hyperalgesia (OIH) and Tolerance
NCT01681264
TERMINATED
PHASE4
Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
NCT02117583
COMPLETED
PHASE1
The Pharmacokinetics and Pharmacodynamics of a Single Acute Dose of a Hemp-derived Oral Product With a 1:1 Ratio of CBD:CBD-A
NCT05049733
COMPLETED
PHASE1
Evaluation of the Interactions of Cannabidiol (CBD) With Morphine
NCT05143424
RECRUITING
PHASE1
A Relative Bioavailability Study of Oxycodone 5 mg / Ibuprofen 400 mg Tablets Under Non-fasting Conditions
NCT00864357
COMPLETED
PHASE1