The Potential Application of Plasma-Activated Water in Fibromyalgia Patients

Обзор

Fibromyalgia is a chronic syndrome characterized by widespread pain that is commonly observed in pain, rheumatology, or rehabilitation clinics. Previous studies have suggested a fibromyalgia prevalence rate of approximately 2%. Currently, evidence shows that fibromyalgia might be partially associated with increased oxidative stress, caused by mitochondrial abnormalities, genetic abnormalities, and excessive metal intake. Some research teams have experimented with dietary adjustments to control oxidative stress, but the relationship between diet and oxidative stress has not been conclusively confirmed. Plasma-activated water is a method of storing the high-energy benefits of water and effectively utilizing its energy. It also improves solubility and conductivity at room temperature. It involves activating nano gold particles with a specific wavelength light source to create surface plasmon resonance, resulting in thermoelectrons. These thermoelectrons then disrupt or reduce the hydrogen bonding capacity between water molecules in the tetrahedral chemical structure network, leading to the formation of smaller water molecules known as plasma-activated water. Studies on animals have shown that plasma-activated water possesses free radical-scavenging and antioxidant properties. It can reduce liver oxidative stress damage induced by sleep deprivation and is non-toxic. Recent studies have shown that plasma-activated water can treat cancer, chronic diseases, and degenerative conditions in animal models. In a lung cancer animal model, combining plasma-activated water with cisplatin chemotherapy increased the mice's survival time. In an animal model with chronic kidney disease, drinking plasma-activated water reduced fibronectin expression and slowed kidney fibrosis. Plasma-activated water reduced oxidative stress in an animal model of chronic sleep deprivation-induced liver damage, thereby enhancing the antioxidant and anti-inflammatory capabilities of the liver cells. In an animal model with Alzheimer's disease, it reduced amyloid-β protein expression and improved memory. In a rat model with Parkinson's disease, plasma-activated water suppressed inflammation and protected nerve cells. Since plasma-activated water has demonstrated antioxidant effects in mouse and rat animal models and previous clinical trials have shown that drinking plasma-activated water does not have toxic reactions and does not significantly affect drug metabolism in the human body, this study aims to assess the safety and potential symptom improvement effects of long-term consumption of plasma-activated water in fibromyalgia patients.

Вмешательства

• Пищевая добавка Plasma-Activated Water
  Plasma-activated water is a method of storing the high-energy benefits of water and effectively utilizing its energy. It also enhances properties such as solubility and conductivity at room temperature. It involves activating nano gold particles with a specific wavelength light source to create surface plasmon resonance, resulting in thermoelectrons. These thermoelectrons then disrupt or reduce the hydrogen bonding capacity between water molecules in the tetrahedral chemical structure network, l
• Другое Placebo
  Typical drinking water

Первичные конечные точки

• Fasting Blood Levels of Selected Laboratory Biomarkers [Срок оценки: Pre-test visit, after at least 6 hours of fasting]

Критерии участия

Критерии включения

• Currently experiencing widespread bodily pain for a duration of at least three months and diagnosed by a clinical specialist as a fibromyalgia patient.
• Aged between 20 and 75 years.
• Clear understanding and the ability to communicate with the researchers in Mandarin or Taiwanese dialect through spoken or written language.
• Willingness to participate in this research after receiving an explanation and the ability to cooperate with the research procedures.

Критерии исключения

• Malignant tumors.
• Currently experiencing an acute infection.
• Concurrent central nervous system disorders such as stroke or Parkinson's disease.
• Concurrent endocrine system disorders such as hypothyroidism.
• Significant autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, lupus, and others.
• Currently pregnant.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Medical University Hospital — Taipei

Публикации

• Sanchez-Dominguez B, Bullon P, Roman-Malo L, Marin-Aguilar F, Alcocer-Gomez E, Carrion AM, Sanchez-Alcazar JA, Cordero MD. Oxidative stress, mitochondrial dysfunction and, inflammation common events in skin of patients with Fibromyalgia. Mitochondrion. 2015 Mar;21:69-75. doi: 10.1016/j.mito.2015.01.010. Epub 2015 Feb 7. PMID 25662535
• Rus A, Robles-Fernandez I, Martinez-Gonzalez LJ, Carmona R, Alvarez-Cubero MJ. Influence of Oxidative Stress-Related Genes on Susceptibility to Fibromyalgia. Nurs Res. 2021 Jan/Feb;70(1):44-50. doi: 10.1097/NNR.0000000000000480. PMID 32991532
• Tel Adiguzel K, Koroglu O, Yasar E, Tan AK, Samur G. The relationship between dietary total antioxidant capacity, clinical parameters, and oxidative stress in fibromyalgia syndrome: A novel point of view. Turk J Phys Med Rehabil. 2022 Jun 1;68(2):262-270. doi: 10.5606/tftrd.2022.9741. eCollection 2022 Jun. PMID 35989949
• Chen HC, Yang CP, Hong CT, Hsu CT, Hu CC, Liu YC. Potential of Plasmon-Activated Water as a Comprehensive Active Green Energy Resource. ACS Omega. 2019 May 2;4(5):8007-8014. doi: 10.1021/acsomega.9b00463. eCollection 2019 May 31. PMID 31459889
• Yang CP, Liu YC. Therapeutics for Inflammatory-Related Diseases Based on Plasmon-Activated Water: A Review. Int J Mol Sci. 2018 May 28;19(6):1589. doi: 10.3390/ijms19061589. PMID 29843406
• Cheng CH, Lin KJ, Hong CT, Wu D, Chang HM, Liu CH, Hsiao IT, Yang CP, Liu YC, Hu CJ. Plasmon-Activated Water Reduces Amyloid Burden and Improves Memory in Animals with Alzheimer's Disease. Sci Rep. 2019 Sep 13;9(1):13252. doi: 10.1038/s41598-019-49731-8. PMID 31520077

Идентификаторы

NCT: NCT07659236 · N202311061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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