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Recruiting NCT07659236

The Potential Application of Plasma-Activated Water in Fibromyalgia Patients

No phase Interventional Safety and Potential Symptom Improvement Effects of Long Term Consumption of Plasma Activated Water in Fibromyalgia Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma-Activated Water, Placebo.
Who it may be relevant to
Registry conditions: Safety and Potential Symptom Improvement Effects of Long Term Consumption of Plasma Activated Water in Fibromyalgia Patients. Basic parameters: 20 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Dietary supplement 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
  • Other Placebo
    Typical drinking water

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Taipei Medical University Hospital — Taipei

Publications

  • 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

Identifiers

NCT: NCT07659236 · N202311061

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗