NCT02523794

Study of Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis

A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Revalesio Corporation · Industry
• Sex: Female
• Age: 16 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of electro-kinetically modified water (EMW) beverage, consumed twice daily (BID) for 3 months in the management of endometriosis associated pain, and to evaluate the effect of EMW consumption on analgesic use for endometriosis associated pain.

Detailed description

This is a single center, double-blind, placebo controlled, randomized study to assess the efficacy of EMW versus placebo in the treatment of premenopausal women (16-49 years of age) with endometriosis associated pain. Approximately 40 subjects with endometriosis will be enrolled at Madigan Army Medical Center (MAMC). Subjects will be asked to consume EMW (or placebo) for three months. Subjects will record daily pain levels and other symptoms associated with endometriosis in an electronic diary. In addition to standard of care for this condition, the investigator will monitor the subjects at baseline, Month 1, and Month 3 visits, which will consist of patient questionnaires, blood sampling, and Adverse Events monitoring.

Conditions

• Pelvic Pain

Interventions

Type	Name	Description
OTHER	Electro-kinetically Modified Water	Subjects assigned to this arm will receive the EMW
OTHER	Placebo	Purified Drinking Water

Timeline

• Start date: 2015-08-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-08-14
• Last updated: 2018-01-25

Locations

1 site across 1 country: United States