Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-04-18 @ 6:45 PM
Study NCT ID:
NCT02523794
Status:
TERMINATED
Last Update Posted:
2018-01-25
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
Sponsor:
Revalesio Corporation
Organization:
Study Overview
Official Title:
A Double Blind, Placebo-controlled Study Evaluating an Electro-kinetically Modified Water for the Treatment of Pain Associated With Endometriosis
Status:
TERMINATED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: