search
Back to results

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

Primary Purpose

Pain, Chronic, Opioid Dependence, Opioid Use

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Root.Health Dietary Supplement
Sponsored by
Hudson Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Exclusion Criteria: under 18 years of age participants who are pregnant or breastfeeding at time of study recruitment To reduce the likelihood of a study population whose recreational choices may affect the study endpoints, the investigators will screen potential participants during the enrollment phase using exclusion criteria based on health history, including recreational opiate drug use.

Sites / Locations

  • Hudson Medical

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daily Supplement Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain Improvements
To evaluate if a 3-month Root.Health supplementation regimen changes Brief Pain Inventory (BPI) Short Form scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each item of the BPI, patients select a whole number on scale of 0-10, where 0 indicates no pain and 10 indicates worst possible pain. Lower scores are associated with less severe episodes of pain.
Functional Improvements
To evaluate if a 3-month Root.Health supplementation regimen changes Oswestry Disability Index (ODI) scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each question on the ODI, patient select the one whole number that describes how much the pain has interfered with the listed activities. The ODI is scored on a scale of 0-10, where 0 indicates no interference thus being able to do all activities and 10 indicates complete interference so the patient is unable to do the activity. Lower scores are associated with less severe episodes of pain.
Reduced Opioid Dependency
To evaluate if a 3-month Root.Health supplementation regimen affects opiate consumption habits from time of study enrollment in an opiate-using chronic pain population. This information will be gathered through subjective patient interviews at each month's follow up, inquiring about how often the patient is taking a prescribed medication. The study participants will report if they have continued their opioid medications at regular intervals as prescribed, or if they have taken less or more than the maximum prescribed dose.

Full Information

First Posted
April 7, 2023
Last Updated
September 25, 2023
Sponsor
Hudson Medical
Collaborators
Ethos Research & Development
search

1. Study Identification

Unique Protocol Identification Number
NCT05896878
Brief Title
The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Official Title
The Effects of Daily Anti-inflammatory Supplementation on Foundation Pain Index Scores in Chronic Opiate Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hudson Medical
Collaborators
Ethos Research & Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Opioid Dependence, Opioid Use, Inflammation Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Daily Supplement Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Root.Health Dietary Supplement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effects on Foundation Pain Index (FPI) scores
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Pain Improvements
Description
To evaluate if a 3-month Root.Health supplementation regimen changes Brief Pain Inventory (BPI) Short Form scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each item of the BPI, patients select a whole number on scale of 0-10, where 0 indicates no pain and 10 indicates worst possible pain. Lower scores are associated with less severe episodes of pain.
Time Frame
3 months
Title
Functional Improvements
Description
To evaluate if a 3-month Root.Health supplementation regimen changes Oswestry Disability Index (ODI) scores from time of study enrollment in an opiate-using chronic pain population. These tests are included in the standard of care for chronic pain patients. For each question on the ODI, patient select the one whole number that describes how much the pain has interfered with the listed activities. The ODI is scored on a scale of 0-10, where 0 indicates no interference thus being able to do all activities and 10 indicates complete interference so the patient is unable to do the activity. Lower scores are associated with less severe episodes of pain.
Time Frame
3 months
Title
Reduced Opioid Dependency
Description
To evaluate if a 3-month Root.Health supplementation regimen affects opiate consumption habits from time of study enrollment in an opiate-using chronic pain population. This information will be gathered through subjective patient interviews at each month's follow up, inquiring about how often the patient is taking a prescribed medication. The study participants will report if they have continued their opioid medications at regular intervals as prescribed, or if they have taken less or more than the maximum prescribed dose.
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Exclusion Criteria: under 18 years of age participants who are pregnant or breastfeeding at time of study recruitment To reduce the likelihood of a study population whose recreational choices may affect the study endpoints, the investigators will screen potential participants during the enrollment phase using exclusion criteria based on health history, including recreational opiate drug use.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathann Kuo, MD
Organizational Affiliation
Medical Director, Hudson Medical
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hudson Medical
City
New York
State/Province
New York
ZIP/Postal Code
10014
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10933890
Citation
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.
Results Reference
background
PubMed Identifier
32644558
Citation
Al Amin ASM, Gupta V. Vitamin B12 (Cobalamin). 2023 Jul 16. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK559132/
Results Reference
background
PubMed Identifier
22332101
Citation
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.
Results Reference
background
PubMed Identifier
16563357
Citation
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.
Results Reference
background
PubMed Identifier
18662800
Citation
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.
Results Reference
background
PubMed Identifier
32495188
Citation
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.
Results Reference
background
PubMed Identifier
31935866
Citation
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.
Results Reference
background
PubMed Identifier
32860400
Citation
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.
Results Reference
background
PubMed Identifier
26338495
Citation
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.
Results Reference
background
PubMed Identifier
27043287
Citation
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.
Results Reference
background
PubMed Identifier
22342951
Citation
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.
Results Reference
background
PubMed Identifier
27193019
Citation
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.
Results Reference
background
PubMed Identifier
22001064
Citation
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.
Results Reference
background
PubMed Identifier
27488221
Citation
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.
Results Reference
background
PubMed Identifier
33558182
Citation
Cheah IK, Halliwell B. Ergothioneine, recent developments. Redox Biol. 2021 Jun;42:101868. doi: 10.1016/j.redox.2021.101868. Epub 2021 Jan 26.
Results Reference
background
PubMed Identifier
33441348
Citation
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.
Results Reference
background
PubMed Identifier
35427389
Citation
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.
Results Reference
background
PubMed Identifier
31971706
Citation
Dydyk AM, Conermann T. Chronic Pain. 2023 Jul 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK553030/
Results Reference
background
PubMed Identifier
31861069
Citation
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.
Results Reference
background
PubMed Identifier
34990506
Citation
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.
Results Reference
background
PubMed Identifier
26174047
Citation
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.
Results Reference
background
PubMed Identifier
18549505
Citation
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.
Results Reference
background
PubMed Identifier
32013287
Citation
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. Erratum In: Pain Physician. 2020 Mar;23(2):235.
Results Reference
background
PubMed Identifier
22887802
Citation
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.
Results Reference
background
PubMed Identifier
19061005
Citation
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.
Results Reference
background
PubMed Identifier
34887680
Citation
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.
Results Reference
background
PubMed Identifier
35370675
Citation
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.
Results Reference
background
PubMed Identifier
29851075
Citation
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.
Results Reference
background
PubMed Identifier
22588629
Citation
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.
Results Reference
background
PubMed Identifier
28096758
Citation
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.
Results Reference
background
PubMed Identifier
23076948
Citation
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.
Results Reference
background
PubMed Identifier
27638428
Citation
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.
Results Reference
background
PubMed Identifier
33806754
Citation
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.
Results Reference
background
PubMed Identifier
33488599
Citation
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.
Results Reference
background
PubMed Identifier
29029466
Citation
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.
Results Reference
background
PubMed Identifier
29158945
Citation
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.
Results Reference
background
PubMed Identifier
33381205
Citation
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.
Results Reference
background
PubMed Identifier
21206541
Citation
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.
Results Reference
background
PubMed Identifier
23717767
Citation
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.
Results Reference
background
PubMed Identifier
22605974
Citation
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.
Results Reference
background
PubMed Identifier
35010998
Citation
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.
Results Reference
background
PubMed Identifier
9617340
Citation
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.
Results Reference
background
PubMed Identifier
28726051
Citation
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.
Results Reference
background
PubMed Identifier
15545677
Citation
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.
Results Reference
background
PubMed Identifier
33914984
Citation
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.
Results Reference
background
PubMed Identifier
30371340
Citation
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.
Results Reference
background
PubMed Identifier
12646250
Citation
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.
Results Reference
background
PubMed Identifier
18837637
Citation
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.
Results Reference
background
PubMed Identifier
33041781
Citation
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.
Results Reference
background
PubMed Identifier
17291458
Citation
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.
Results Reference
background
PubMed Identifier
30806743
Citation
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.
Results Reference
background
PubMed Identifier
32973438
Citation
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.
Results Reference
background
PubMed Identifier
31401380
Citation
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.
Results Reference
background
PubMed Identifier
34715934
Citation
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.
Results Reference
background
PubMed Identifier
28820474
Citation
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.
Results Reference
background
PubMed Identifier
18442638
Citation
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.
Results Reference
background
PubMed Identifier
17426506
Citation
Zhang JM, An J. Cytokines, inflammation, and pain. Int Anesthesiol Clin. 2007 Spring;45(2):27-37. doi: 10.1097/AIA.0b013e318034194e.
Results Reference
background
PubMed Identifier
24455309
Citation
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.
Results Reference
background
PubMed Identifier
18381589
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs