The Potential Application of Plasma-Activated Water in Fibromyalgia Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Safety and Potential Symptom Improvement Effects of Long Term Consumption of Plasma Activated Water in Fibromyalgia Patients
• Intervention / Treatment: Dietary supplement: Plasma-Activated Water; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 110
    • Recruiting
    • Taipei Medical University Hospital
    • Contact: Jiunn-Horng Kang, MD, PhD; Phone Number: 3242 +886-2-27372181; Email: jhk@tmu.edu.tw
    • Principal Investigator: Jiunn-Horng Kang, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fibromyalgia Patients with Plasma-Activated Water Use	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, leading to the formation of smaller water molecules known as plasma-activated water.
Placebo Comparator: Fibromyalgia Patients with Placebo Use	Other: Placebo; Typical drinking water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful 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 record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: N202311061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No