The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients

NCT05896878 | Terminated DMC

• 1 other identifier: BRANY #22-02-797-993
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Chronic; Opioid Dependence; Opioid Use; Inflammation Chronic

Outcome Measures

Primary Outcomes (1)

• Effects on Foundation Pain Index (FPI) scores

  To determine if a 3-month Root.Health supplementation course changes urine levels of Foundation Pain Index (FPI) scores mechanistic pain biomarkers in an opiate-using chronic pain population. Previous validation studies have demonstrated that higher FPI scores, represented by a greater number of abnormal biomarkers, indicate abnormal biochemical function is more likely to contribute to painful symptoms. Lower FPI scores, represented by a lower number of abnormal biomarkers, indicate biochemical function is unremarkable and is therefore less likely to be a contributor to painful symptoms. As such, the investigators will only include study participants with baseline FPI scores between 20-100 to select a study population in which abnormal biochemical functioning is more likely to be contributing to chronic pain symptoms. Scores between 0-20 are considered unremarkable.

  3 months

Secondary Outcomes (3)

• Pain Improvements

  3 months

• Functional Improvements

  3 months

• Reduced Opioid Dependency

  3 months

Study Arms (1)

Daily Supplement Treatment

EXPERIMENTAL

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.

Dietary Supplement: Root.Health Dietary Supplement

Interventions

Root.Health Dietary Supplement 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.

Daily Supplement Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• under 18 years of age
• participants who are pregnant or breastfeeding at time of study recruitment

Sponsors & Collaborators

• Hudson Medical: lead
• Ethos Research & Development: collaborator

Study Sites (1)

Hudson Medical

New York, New York, 10014, United States

Location

Related Publications (59)

• Abbud W, Habinowski S, Zhang JZ, Kendrew J, Elkairi FS, Kemp BE, Witters LA, Ismail-Beigi F. Stimulation of AMP-activated protein kinase (AMPK) is associated with enhancement of Glut1-mediated glucose transport. Arch Biochem Biophys. 2000 Aug 15;380(2):347-52. doi: 10.1006/abbi.2000.1935.

  PMID: 10933890 BACKGROUND

• Al Amin ASM, Gupta V. Vitamin B12 (Cobalamin). 2023 Jul 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559132/

  PMID: 32644558 BACKGROUND

• Allen LH. Vitamin B-12. Adv Nutr. 2012 Jan;3(1):54-5. doi: 10.3945/an.111.001370. Epub 2012 Jan 5. No abstract available.

  PMID: 22332101 BACKGROUND

• Aggarwal BB, Shishodia S. Molecular targets of dietary agents for prevention and therapy of cancer. Biochem Pharmacol. 2006 May 14;71(10):1397-421. doi: 10.1016/j.bcp.2006.02.009. Epub 2006 Feb 23.

  PMID: 16563357 BACKGROUND

• Aggarwal BB, Harikumar KB. Potential therapeutic effects of curcumin, the anti-inflammatory agent, against neurodegenerative, cardiovascular, pulmonary, metabolic, autoimmune and neoplastic diseases. Int J Biochem Cell Biol. 2009 Jan;41(1):40-59. doi: 10.1016/j.biocel.2008.06.010. Epub 2008 Jul 9.

  PMID: 18662800 BACKGROUND

• Amirdelfan K, Pope JE, Gunn J, Hill MM, Cotten BM, Beresh JE, Dobecki D, Miller N, Mehta P, Girardi G, Deer TR. Clinical Validation of a Multi-Biomarker Assay for the Evaluation of Chronic Pain Patients in a Cross-Sectional, Observational Study. Pain Ther. 2020 Dec;9(2):511-529. doi: 10.1007/s40122-020-00175-3. Epub 2020 Jun 3.

  PMID: 32495188 BACKGROUND

• Anh NH, Kim SJ, Long NP, Min JE, Yoon YC, Lee EG, Kim M, Kim TJ, Yang YY, Son EY, Yoon SJ, Diem NC, Kim HM, Kwon SW. Ginger on Human Health: A Comprehensive Systematic Review of 109 Randomized Controlled Trials. Nutrients. 2020 Jan 6;12(1):157. doi: 10.3390/nu12010157.

  PMID: 31935866 BACKGROUND

• Bailey RL, Jun S, Murphy L, Green R, Gahche JJ, Dwyer JT, Potischman N, McCabe GP, Miller JW. High folic acid or folate combined with low vitamin B-12 status: potential but inconsistent association with cognitive function in a nationally representative cross-sectional sample of US older adults participating in the NHANES. Am J Clin Nutr. 2020 Dec 10;112(6):1547-1557. doi: 10.1093/ajcn/nqaa239.

  PMID: 32860400 BACKGROUND

• Asahi T, Wu X, Shimoda H, Hisaka S, Harada E, Kanno T, Nakamura Y, Kato Y, Osawa T. A mushroom-derived amino acid, ergothioneine, is a potential inhibitor of inflammation-related DNA halogenation. Biosci Biotechnol Biochem. 2016;80(2):313-7. doi: 10.1080/09168451.2015.1083396. Epub 2015 Sep 4.

  PMID: 26338495 BACKGROUND

• Bannister K, Dickenson AH. What do monoamines do in pain modulation? Curr Opin Support Palliat Care. 2016 Jun;10(2):143-8. doi: 10.1097/SPC.0000000000000207.

  PMID: 27043287 BACKGROUND

• Benson KF, Ager DM, Landes B, Aruoma OI, Jensen GS. Improvement of joint range of motion (ROM) and reduction of chronic pain after consumption of an ergothioneine-containing nutritional supplement. Prev Med. 2012 May;54 Suppl:S83-9. doi: 10.1016/j.ypmed.2012.02.001. Epub 2012 Feb 9.

  PMID: 22342951 BACKGROUND

• Calvo MS, Mehrotra A, Beelman RB, Nadkarni G, Wang L, Cai W, Goh BC, Kalaras MD, Uribarri J. A Retrospective Study in Adults with Metabolic Syndrome: Diabetic Risk Factor Response to Daily Consumption of Agaricus bisporus (White Button Mushrooms). Plant Foods Hum Nutr. 2016 Sep;71(3):245-51. doi: 10.1007/s11130-016-0552-7.

  PMID: 27193019 BACKGROUND

• Cheah IK, Halliwell B. Ergothioneine; antioxidant potential, physiological function and role in disease. Biochim Biophys Acta. 2012 May;1822(5):784-93. doi: 10.1016/j.bbadis.2011.09.017. Epub 2011 Oct 4.

  PMID: 22001064 BACKGROUND

• Cheah IK, Tang RM, Yew TS, Lim KH, Halliwell B. Administration of Pure Ergothioneine to Healthy Human Subjects: Uptake, Metabolism, and Effects on Biomarkers of Oxidative Damage and Inflammation. Antioxid Redox Signal. 2017 Feb 10;26(5):193-206. doi: 10.1089/ars.2016.6778. Epub 2016 Sep 7.

  PMID: 27488221 BACKGROUND

• Cheah IK, Halliwell B. Ergothioneine, recent developments. Redox Biol. 2021 Jun;42:101868. doi: 10.1016/j.redox.2021.101868. Epub 2021 Jan 26.

  PMID: 33558182 BACKGROUND

• Chen JS, Alfajaro MM, Chow RD, Wei J, Filler RB, Eisenbarth SC, Wilen CB. Non-steroidal anti-inflammatory drugs dampen the cytokine and antibody response to SARS-CoV-2 infection. J Virol. 2021 Mar 10;95(7):e00014-21. doi: 10.1128/JVI.00014-21. Epub 2021 Jan 13.

  PMID: 33441348 BACKGROUND

• Djade CD, Diorio C, Laurin D, Dionne CE. An exploratory identification of biological markers of chronic musculoskeletal pain in the low back, neck, and shoulders. PLoS One. 2022 Apr 15;17(4):e0266999. doi: 10.1371/journal.pone.0266999. eCollection 2022.

  PMID: 35427389 BACKGROUND

• Stretanski MF, Kopitnik NL, Matha A, Conermann T. Chronic Pain. 2025 Sep 28. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553030/

  PMID: 31971706 BACKGROUND

• Ehmedah A, Nedeljkovic P, Dacic S, Repac J, Draskovic Pavlovic B, Vucevic D, Pekovic S, Bozic Nedeljkovic B. Vitamin B Complex Treatment Attenuates Local Inflammation after Peripheral Nerve Injury. Molecules. 2019 Dec 17;24(24):4615. doi: 10.3390/molecules24244615.

  PMID: 31861069 BACKGROUND

• Farah S, Yammine K. A systematic review on the efficacy of vitamin B supplementation on diabetic peripheral neuropathy. Nutr Rev. 2022 Apr 8;80(5):1340-1355. doi: 10.1093/nutrit/nuab116.

  PMID: 34990506 BACKGROUND

• Feng R, Shou JW, Zhao ZX, He CY, Ma C, Huang M, Fu J, Tan XS, Li XY, Wen BY, Chen X, Yang XY, Ren G, Lin Y, Chen Y, You XF, Wang Y, Jiang JD. Transforming berberine into its intestine-absorbable form by the gut microbiota. Sci Rep. 2015 Jul 15;5:12155. doi: 10.1038/srep12155.

  PMID: 26174047 BACKGROUND

• Gonzales AM, Orlando RA. Curcumin and resveratrol inhibit nuclear factor-kappaB-mediated cytokine expression in adipocytes. Nutr Metab (Lond). 2008 Jun 12;5:17. doi: 10.1186/1743-7075-5-17.

  PMID: 18549505 BACKGROUND

• Gunn J, Hill MM, Cotten BM, Deer TR. An Analysis of Biomarkers in Patients with Chronic Pain. Pain Physician. 2020 Jan;23(1):E41-E49.

  PMID: 32013287 BACKGROUND

• Gupta SC, Sung B, Kim JH, Prasad S, Li S, Aggarwal BB. Multitargeting by turmeric, the golden spice: From kitchen to clinic. Mol Nutr Food Res. 2013 Sep;57(9):1510-28. doi: 10.1002/mnfr.201100741. Epub 2012 Aug 13.

  PMID: 22887802 BACKGROUND

• Habib SH, Makpol S, Abdul Hamid NA, Das S, Ngah WZ, Yusof YA. Ginger extract (Zingiber officinale) has anti-cancer and anti-inflammatory effects on ethionine-induced hepatoma rats. Clinics (Sao Paulo). 2008 Dec;63(6):807-13. doi: 10.1590/s1807-59322008000600017.

  PMID: 19061005 BACKGROUND

• Hagedorn JM, Gunn J, Budwany R, D'Souza RS, Chakravarthy K, Deer TR. How Well Do Current Laboratory Biomarkers Inform Clinical Decision-Making in Chronic Pain Management? J Pain Res. 2021 Dec 3;14:3695-3710. doi: 10.2147/JPR.S311974. eCollection 2021.

  PMID: 34887680 BACKGROUND

• Fu TT, Shen L. Ergothioneine as a Natural Antioxidant Against Oxidative Stress-Related Diseases. Front Pharmacol. 2022 Mar 18;13:850813. doi: 10.3389/fphar.2022.850813. eCollection 2022.

  PMID: 35370675 BACKGROUND

• Halliwell B, Cheah IK, Tang RMY. Ergothioneine - a diet-derived antioxidant with therapeutic potential. FEBS Lett. 2018 Oct;592(20):3357-3366. doi: 10.1002/1873-3468.13123. Epub 2018 Jun 15.

  PMID: 29851075 BACKGROUND

• Hosseinzadeh H, Moallem SA, Moshiri M, Sarnavazi MS, Etemad L. Anti-nociceptive and anti-inflammatory effects of cyanocobalamin (vitamin B12) against acute and chronic pain and inflammation in mice. Arzneimittelforschung. 2012 Jul;62(7):324-9. doi: 10.1055/s-0032-1311635. Epub 2012 May 15.

  PMID: 22588629 BACKGROUND

• Jung YP, Earnest CP, Koozehchian M, Galvan E, Dalton R, Walker D, Rasmussen C, Murano PS, Greenwood M, Kreider RB. Effects of acute ingestion of a pre-workout dietary supplement with and without p-synephrine on resting energy expenditure, cognitive function and exercise performance. J Int Soc Sports Nutr. 2017 Jan 12;14:3. doi: 10.1186/s12970-016-0159-2. eCollection 2017.

  PMID: 28096758 BACKGROUND

• Kumar S, Ahuja V, Sankar MJ, Kumar A, Moss AC. Curcumin for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2012 Oct 17;10:CD008424. doi: 10.1002/14651858.CD008424.pub2.

  PMID: 23076948 BACKGROUND

• Kunnumakkara AB, Bordoloi D, Padmavathi G, Monisha J, Roy NK, Prasad S, Aggarwal BB. Curcumin, the golden nutraceutical: multitargeting for multiple chronic diseases. Br J Pharmacol. 2017 Jun;174(11):1325-1348. doi: 10.1111/bph.13621. Epub 2016 Oct 21.

  PMID: 27638428 BACKGROUND

• Lam-Sidun D, Peters KM, Borradaile NM. Mushroom-Derived Medicine? Preclinical Studies Suggest Potential Benefits of Ergothioneine for Cardiometabolic Health. Int J Mol Sci. 2021 Mar 23;22(6):3246. doi: 10.3390/ijms22063246.

  PMID: 33806754 BACKGROUND

• Li L, Li J, Gao M, Fan H, Wang Y, Xu X, Chen C, Liu J, Kim J, Aliyari R, Zhang J, Jin Y, Li X, Ma F, Shi M, Cheng G, Yang H. Interleukin-8 as a Biomarker for Disease Prognosis of Coronavirus Disease-2019 Patients. Front Immunol. 2021 Jan 8;11:602395. doi: 10.3389/fimmu.2020.602395. eCollection 2020.

  PMID: 33488599 BACKGROUND

• Li J, Zhang CX, Liu YM, Chen KL, Chen G. A comparative study of anti-aging properties and mechanism: resveratrol and caloric restriction. Oncotarget. 2017 Aug 9;8(39):65717-65729. doi: 10.18632/oncotarget.20084. eCollection 2017 Sep 12.

  PMID: 29029466 BACKGROUND

• Liu T, Zhang L, Joo D, Sun SC. NF-kappaB signaling in inflammation. Signal Transduct Target Ther. 2017;2:17023-. doi: 10.1038/sigtrans.2017.23. Epub 2017 Jul 14.

  PMID: 29158945 BACKGROUND

• Majeed M, Majeed S, Nagabhushanam K. Efficacy and Safety of Tetrahydrocurcuminoids for the Treatment of Canker Sore and Gingivitis. Evid Based Complement Alternat Med. 2020 Dec 16;2020:6611877. doi: 10.1155/2020/6611877. eCollection 2020.

  PMID: 33381205 BACKGROUND

• Maroon JC, Bost JW, Maroon A. Natural anti-inflammatory agents for pain relief. Surg Neurol Int. 2010 Dec 13;1:80. doi: 10.4103/2152-7806.73804.

  PMID: 21206541 BACKGROUND

• Mashhadi NS, Ghiasvand R, Askari G, Hariri M, Darvishi L, Mofid MR. Anti-oxidative and anti-inflammatory effects of ginger in health and physical activity: review of current evidence. Int J Prev Med. 2013 Apr;4(Suppl 1):S36-42.

  PMID: 23717767 BACKGROUND

• Mobasheri A, Henrotin Y, Biesalski HK, Shakibaei M. Scientific evidence and rationale for the development of curcumin and resveratrol as nutraceutricals for joint health. Int J Mol Sci. 2012;13(4):4202-4232. doi: 10.3390/ijms13044202. Epub 2012 Mar 30.

  PMID: 22605974 BACKGROUND

• Moon JM, Ratliff KM, Hagele AM, Stecker RA, Mumford PW, Kerksick CM. Absorption Kinetics of Berberine and Dihydroberberine and Their Impact on Glycemia: A Randomized, Controlled, Crossover Pilot Trial. Nutrients. 2021 Dec 28;14(1):124. doi: 10.3390/nu14010124.

  PMID: 35010998 BACKGROUND

• Nakamura Y, Ohto Y, Murakami A, Osawa T, Ohigashi H. Inhibitory effects of curcumin and tetrahydrocurcuminoids on the tumor promoter-induced reactive oxygen species generation in leukocytes in vitro and in vivo. Jpn J Cancer Res. 1998 Apr;89(4):361-70. doi: 10.1111/j.1349-7006.1998.tb00572.x.

  PMID: 9617340 BACKGROUND

• Park JS, Park D, Ko PW, Kang K, Lee HW. Serum methylmalonic acid correlates with neuropathic pain in idiopathic Parkinson's disease. Neurol Sci. 2017 Oct;38(10):1799-1804. doi: 10.1007/s10072-017-3056-9. Epub 2017 Jul 19.

  PMID: 28726051 BACKGROUND

• Peabody JW, Luck J, Glassman P, Jain S, Hansen J, Spell M, Lee M. Measuring the quality of physician practice by using clinical vignettes: a prospective validation study. Ann Intern Med. 2004 Nov 16;141(10):771-80. doi: 10.7326/0003-4819-141-10-200411160-00008.

  PMID: 15545677 BACKGROUND

• Pourhabibi-Zarandi F, Shojaei-Zarghani S, Rafraf M. Curcumin and rheumatoid arthritis: A systematic review of literature. Int J Clin Pract. 2021 Oct;75(10):e14280. doi: 10.1111/ijcp.14280. Epub 2021 May 24.

  PMID: 33914984 BACKGROUND

• Qu H, Guo M, Chai H, Wang WT, Gao ZY, Shi DZ. Effects of Coenzyme Q10 on Statin-Induced Myopathy: An Updated Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Oct 2;7(19):e009835. doi: 10.1161/JAHA.118.009835.

  PMID: 30371340 BACKGROUND

• Rahman I, Gilmour PS, Jimenez LA, Biswas SK, Antonicelli F, Aruoma OI. Ergothioneine inhibits oxidative stress- and TNF-alpha-induced NF-kappa B activation and interleukin-8 release in alveolar epithelial cells. Biochem Biophys Res Commun. 2003 Mar 21;302(4):860-4. doi: 10.1016/s0006-291x(03)00224-9.

  PMID: 12646250 BACKGROUND

• Rosenblum A, Marsch LA, Joseph H, Portenoy RK. Opioids and the treatment of chronic pain: controversies, current status, and future directions. Exp Clin Psychopharmacol. 2008 Oct;16(5):405-16. doi: 10.1037/a0013628.

  PMID: 18837637 BACKGROUND

• Sharifi-Rad J, Rayess YE, Rizk AA, Sadaka C, Zgheib R, Zam W, Sestito S, Rapposelli S, Neffe-Skocinska K, Zielinska D, Salehi B, Setzer WN, Dosoky NS, Taheri Y, El Beyrouthy M, Martorell M, Ostrander EA, Suleria HAR, Cho WC, Maroyi A, Martins N. Turmeric and Its Major Compound Curcumin on Health: Bioactive Effects and Safety Profiles for Food, Pharmaceutical, Biotechnological and Medicinal Applications. Front Pharmacol. 2020 Sep 15;11:01021. doi: 10.3389/fphar.2020.01021. eCollection 2020.

  PMID: 33041781 BACKGROUND

• Shakibaei M, John T, Schulze-Tanzil G, Lehmann I, Mobasheri A. Suppression of NF-kappaB activation by curcumin leads to inhibition of expression of cyclo-oxygenase-2 and matrix metalloproteinase-9 in human articular chondrocytes: Implications for the treatment of osteoarthritis. Biochem Pharmacol. 2007 May 1;73(9):1434-45. doi: 10.1016/j.bcp.2007.01.005. Epub 2007 Jan 7.

  PMID: 17291458 BACKGROUND

• Sforzini L, Nettis MA, Mondelli V, Pariante CM. Inflammation in cancer and depression: a starring role for the kynurenine pathway. Psychopharmacology (Berl). 2019 Oct;236(10):2997-3011. doi: 10.1007/s00213-019-05200-8. Epub 2019 Feb 26.

  PMID: 30806743 BACKGROUND

• Staats Pires A, Heng B, Tan VX, Latini A, Russo MA, Santarelli DM, Bailey D, Wynne K, O'Brien JA, Guillemin GJ, Austin PJ. Kynurenine, Tetrahydrobiopterin, and Cytokine Inflammatory Biomarkers in Individuals Affected by Diabetic Neuropathic Pain. Front Neurosci. 2020 Aug 21;14:890. doi: 10.3389/fnins.2020.00890. eCollection 2020.

  PMID: 32973438 BACKGROUND

• Tan L, Wang Y, Ai G, Luo C, Chen H, Li C, Zeng H, Xie J, Chen J, Su Z. Dihydroberberine, a hydrogenated derivative of berberine firstly identified in Phellodendri Chinese Cortex, exerts anti-inflammatory effect via dual modulation of NF-kappaB and MAPK signaling pathways. Int Immunopharmacol. 2019 Oct;75:105802. doi: 10.1016/j.intimp.2019.105802. Epub 2019 Aug 8.

  PMID: 31401380 BACKGROUND

• Tian X, Cioccoloni G, Sier JH, Naseem KM, Thorne JL, Moore JB. Ergothioneine supplementation in people with metabolic syndrome (ErgMS): protocol for a randomised, double-blind, placebo-controlled pilot study. Pilot Feasibility Stud. 2021 Oct 29;7(1):193. doi: 10.1186/s40814-021-00929-6.

  PMID: 34715934 BACKGROUND

• Wahab A, Gao K, Jia C, Zhang F, Tian G, Murtaza G, Chen J. Significance of Resveratrol in Clinical Management of Chronic Diseases. Molecules. 2017 Aug 18;22(8):1329. doi: 10.3390/molecules22081329.

  PMID: 28820474 BACKGROUND

• Yin J, Xing H, Ye J. Efficacy of berberine in patients with type 2 diabetes mellitus. Metabolism. 2008 May;57(5):712-7. doi: 10.1016/j.metabol.2008.01.013.

  PMID: 18442638 BACKGROUND

• Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.

  PMID: 17426506 BACKGROUND

• Zhang M, Han W, Hu S, Xu H. Methylcobalamin: a potential vitamin of pain killer. Neural Plast. 2013;2013:424651. doi: 10.1155/2013/424651. Epub 2013 Dec 26.

  PMID: 24455309 BACKGROUND

• Zykova TA, Zhu F, Zhai X, Ma WY, Ermakova SP, Lee KW, Bode AM, Dong Z. Resveratrol directly targets COX-2 to inhibit carcinogenesis. Mol Carcinog. 2008 Oct;47(10):797-805. doi: 10.1002/mc.20437.

  PMID: 18381589 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Jonathann Kuo, MD

  Medical Director, Hudson Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: June 9, 2023
• Study Start: July 10, 2023
• Primary Completion: August 10, 2024
• Study Completion: September 10, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)