Oral Curcumin for the Treatment of Pain of Thumb Base Joint (CMC) Arthritis

Официальное название

A Randomized Controlled Trial of Oral Curcumin for the Treatment of Pain of CMC Arthritis

Обзор

The goal of this clinical trial is to learn about the use of turmeric (Curcumin) as a treatment for pain of thumb-joint arthritis. Turmeric is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for thumb-joint arthritis. The main question\[s\] it aims to answer are: * Is Turmeric more effective than placebo at relieving pain for thumb-joint arthritis? A placebo is a look-alike substance that contains no active drug. * Is Turmeric more effective than placebo at improving patient-reported outcomes for CMC arthritis? * Is Turmeric safe for participants with thumb-joint arthritis? Participants will: * take 4 weeks of daily Turmeric capsules, * take 4 weeks of daily placebo capsules * answer daily surveys about how they are feeling and functioning.

Подробное описание

This randomized controlled trial of oral curcumin for the treatment of pain of CMC arthritis will investigate the therapeutic potential of curcumin as an oral treatment for pain of CMC arthritis. Rationale: Curcumin is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for knee osteoarthritis, however no clinical trial has been performed to establish efficacy of curcumin in humans for CMC arthritis. Hypothesis: Curcumin is more effective than placebo for relieving pain and improving patient-reported outcomes for CMC arthritis Study Design: The study design will be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the Curcumin or control and then crossover to the other condition for 4 additional weeks. Patients will take the oral curcumin or control placebo capsule twice daily. Subjects will be advised to observe adverse effects.

The study design will be a double-blind randomized control trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 4 weeks of the case (curcumin) or control capsules and then crossover to the other condition for 4 more weeks with a 2-week washout interval between. Patients will take one oral capsule by mouth twice daily. The subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects. If mild to severe adverse events are noticed, the patient's will discontinue the use of the capsules, and appropriate care and observation will be taken. Each condition will last for 4 weeks and then subjects will be contacted by the study coordinator to facilitate crossover into the other condition following a 2-week washout period. To capture any delayed-onset adverse events, subjects will attend a follow-up visit seven days following the last dose of the curcumin capsule.

Вмешательства

• Препарат Curcumin
  500 mg capsule twice daily
• Препарат Placebo
  capsule twice daily

Первичные конечные точки

• Change from Baseline in Pain on the Visual Analog Pain (VAS) Score [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Pain on the Visual Analog Pain (VAS) Score - crossover condition [Срок оценки: Baseline and Week 10, Week 12]

Вторичные конечные точки (12)

• Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Normal Function on the Single Assessment Numerical Evaluation (SANE) Score - crossover condition [Срок оценки: Baseline and Week 10, Week 12]
• Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Quality of Life on the Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health-10 Score - crossover condition [Срок оценки: Baseline and Week 10, Week 12]
• Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score - crossover condition [Срок оценки: Baseline and Week 10, Week 12]
• Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Pain interference on the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE) Score [Срок оценки: Baseline and Week 10, Week 12]
• Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index [Срок оценки: Baseline and Week 4, Week 6]
• Change from Baseline in Pain on the Australian/Canadian Hand Osteoarthritis (AUSCAN) Index [Срок оценки: Baseline and Week 10, Week 12]
• Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH). [Срок оценки: Baseline and Week 4]
• Change from Baseline in Disability on The Quick Disability of the Arm, Shoulder (QuickDASH) - crossover condition [Срок оценки: Baseline and Week 10]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.
• Male or female, aged 18 years or older.
• For females, must be willing to use an approved form of birth control during this study. Acceptable forms of birth control:

• Norplant
• IUD (intrauterine device)
• Birth Control Patch
• Depo-Provera
• Sterilization

The following may be used if combined with other birth control methods:

• Condoms
• Diaphragm
• Jellies or foam
• Cervical cap
• Sponge
• For males, must be willing to not father a baby for the duration of the study and for 90 days after the last dose of study drug, or donate to a sperm back during this time. Must be willing to use an approved form of birth control during this time. Acceptable forms of birth control:

• Condoms
• Sterilization
• Daily visual analog pain greater than 5 and ≤ 9 out of 10.
• Duration of pain for greater than 30 days.
• Presence of radiographically confirmed diagnosis of thumb basal joint arthritis

Критерии исключения

• Participant does not speak English.
• Participant is blind.
• Severe cardiac, pulmonary, liver, gastrointestinal and hematological disease (including coagulopathy), and /or renal disease.
• Abnormal hematological, coagulation, and/or liver function test results.
• Coumadin use at time of screening.
• Use of any anticoagulant and antiplatelet medication.
• History of mental illness.
• Participant who is incarcerated.
• History of drug or substance abuse.
• Pre-existing curcumin or turmeric product usage within 3 months of the study period.
• Participant has had a corticosteroid injection ≤ 60 days prior.
• Participant has had prior surgery for osteoarthritis treatment
• Participant who has fibromyalgia and post-operative pain.
• Females who are pregnant, nursing or planning a pregnancy
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP3A4:

• Itraconazole,
• Ketoconazole,
• Azamulin,
• Troleandomycin,
• Verapamil,
• John's wart,
• Phenobarbital,
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C19:

• Nootkatone,
• Ticlopidine,
• Rifampin,
• Omeprazole),
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C8:

• Montelukast,
• Quercetin,
• Phenelzine,
• Rifampin,
• Clopidogrel ,
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2C9:

• Sulfaphenazole,
• Tienilic acid,
• Carbamazepine,
• Apoflutamide ,
• Fluconazole,
• Celecoxib,
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP1A2:

• alpha-Naphthoflavone,
• Furafylline,
• Phenytoin,
• Rifampin,
• Ritonavir,
• smoking,
• Teriflunomide,
• Ciprofloxacin,
• oral contraceptives,
• Allopurinol
• Participants within 14 days of the study procedure taking prescription or non-prescription medication which are substrates of CYP2B6 :

• Sertraline,
• Phencyclidine,
• Thiotepa,
• Ticlopidine,
• Carbamazepine,
• Efavirenz,
• Rifampin,
• Bupropion)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Virginia — Charlottesville

Публикации

• Wolf JM, Atroshi I, Zhou C, Karlsson J, Englund M. Sick Leave After Surgery for Thumb Carpometacarpal Osteoarthritis: A Population-Based Study. J Hand Surg Am. 2018 May;43(5):439-447. doi: 10.1016/j.jhsa.2017.11.019. Epub 2018 Feb 7. PMID 29428245
• Brat GA, Agniel D, Beam A, Yorkgitis B, Bicket M, Homer M, Fox KP, Knecht DB, McMahill-Walraven CN, Palmer N, Kohane I. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018 Jan 17;360:j5790. doi: 10.1136/bmj.j5790. PMID 29343479
• Funk JL, Frye JB, Oyarzo JN, Kuscuoglu N, Wilson J, McCaffrey G, Stafford G, Chen G, Lantz RC, Jolad SD, Solyom AM, Kiela PR, Timmermann BN. Efficacy and mechanism of action of turmeric supplements in the treatment of experimental arthritis. Arthritis Rheum. 2006 Nov;54(11):3452-64. doi: 10.1002/art.22180. PMID 17075840
• Lakhan SE, Ford CT, Tepper D. Zingiberaceae extracts for pain: a systematic review and meta-analysis. Nutr J. 2015 May 14;14:50. doi: 10.1186/s12937-015-0038-8. PMID 25972154
• Goel A, Kunnumakkara AB, Aggarwal BB. Curcumin as "Curecumin": from kitchen to clinic. Biochem Pharmacol. 2008 Feb 15;75(4):787-809. doi: 10.1016/j.bcp.2007.08.016. Epub 2007 Aug 19. PMID 17900536
• Daily JW, Yang M, Park S. Efficacy of Turmeric Extracts and Curcumin for Alleviating the Symptoms of Joint Arthritis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. J Med Food. 2016 Aug;19(8):717-29. doi: 10.1089/jmf.2016.3705. PMID 27533649
• Travica N, Teasdale S, Marx W. Nutraceuticals in mood disorders: current knowledge and future directions. Curr Opin Psychiatry. 2023 Jan 1;36(1):54-59. doi: 10.1097/YCO.0000000000000826. Epub 2022 Aug 29. PMID 36044293
• Hafez Ghoran S, Calcaterra A, Abbasi M, Taktaz F, Nieselt K, Babaei E. Curcumin-Based Nanoformulations: A Promising Adjuvant towards Cancer Treatment. Molecules. 2022 Aug 16;27(16):5236. doi: 10.3390/molecules27165236. PMID 36014474

Идентификаторы

NCT: NCT06359665 · HSR230544

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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