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

Pelvic Pain Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02523794
Study type Interventional
Source Revalesio Corporation
Contact
Status Terminated
Phase N/A
Start date August 2015
Completion date September 2016
View Details
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