The Potential Application of Plasma-Activated Water in Fibromyalgia Patients

NCT07659236 | Recruiting DMC

• 1 other identifier: N202311061
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Safety and Potential Symptom Improvement Effects of Long Term Consumption of Plasma Activated Water in Fibromyalgia Patients

Outcome Measures

Primary Outcomes (1)

• Fasting Blood Levels of Selected Laboratory Biomarkers

  Blood samples will be collected after participants have fasted for at least 6 hours. Samples will be analyzed for selected laboratory biomarkers, including glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or other prespecified analytes. Glucose, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol will be reported in mg/dL; creatinine will be reported in mg/dL; and ALT and AST will be reported in U/L.

  Pre-test visit, after at least 6 hours of fasting

Study Arms (2)

Fibromyalgia Patients with Plasma-Activated Water Use

EXPERIMENTAL

Dietary Supplement: Plasma-Activated Water

Fibromyalgia Patients with Placebo Use

PLACEBO COMPARATOR

Other: Placebo

Interventions

Plasma-Activated Water DIETARY_SUPPLEMENT

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, leading to the formation of smaller water molecules known as plasma-activated water.

Fibromyalgia Patients with Plasma-Activated Water Use

Placebo OTHER

Typical drinking water

Fibromyalgia Patients with Placebo Use

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Related Publications (6)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Related Links

• Comprehensively active condensed water from vapors of plasmon-activated water
• Plasmon-Activated Water can Prolong Existing Sea-Ice Habitats to Potentially Save Polar Bears

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, College of Biomedical Engineering, Taipei Medical University

Model Details: Fibromyalgia Patients

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 22, 2026
• Study Start: July 1, 2024
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

TW (1)