Safety of Orally Administered Neutral pH Super Oxidation Electrolyzed Solution

Safety evaluation of orally administered superoxidation electrolyzed solution with neutral pH in clinically healthy subjects or without decompensated diseases - ORALSES

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000427

Enrollment

Registered

2023-07-21

Start date

2023-08-14

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Interventions

Single group: The patient will receive orally 30 milliliters of Neutral pH Super Oxidation Electrolyzed Solution (also called neutral electrolyzed Saline), administered every 8 hours, for 10 days. The

Saline Solution

Probiotics

Administration, Oral

electrolyzed solution

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 45 years. 2. That they do not present signs or symptoms of an acute illness. 3 In case of suffering from any chronic degenerative disease, which is controlled and without presenting complications. 4. Sign informed written consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Rheumatoid arthritis. 2. Autoimmune diseases. 3. Previously diagnosed heart disease (ischemic). 4. Decompensated systemic chronic disease. 5. Creatinine 1.25 times higher than the normal value or creatinine clearance less than 50 milliliters/minute (Cockfrot and Gault method). 6. Blood hemoglobin less than 10g/Dl. 7. Increase in the last month of diastolic blood pressure of 110 mmHg or more and/or appearance of hematuria or proteinuria greater than 300 milligrams/day. 8. Intestinal pseudo-obstruction. Defined as abdominal pain, with air-fluid levels on AP abdominal radiographs and standing lateral. 9. Pregnant and lactating women. 10. Drug addiction (illegal drugs). 11. Known liver disease with doubling of liver function tests (Aspartate amino transferase (AST), Alanine amino transferase (ALT), Alkaline phosphatase, Bilirubin). 12. Presence of Cancer. 13. Other pathologies at the discretion of the researcher.

Design outcomes

Primary

Measure	Time frame
Adverse Events-AE (Present, Absent). AEs will be classified according to the Common Terminology Criteria for Adverse Events version 5 (CTCAE). Measurement time: Daily until the 15th or until the AEs that arise are resolved.	—

Secondary

Measure	Time frame
Change in blood serum laboratory test values (Na, K, Cl, prothrombin time, partial thromboplastin time, cholesterol, triglycerides, glucose, urea, creatinine, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, albumin, bilirubin, lactate dehydrogenase biometry), in whole blood (hematic biometry and erythrocyte sedimentation rate), in feces (coproparasitoscopic and stool analysis), and in urine (general urinalysis, protein, creatinine, and Na in a random urine sample). Measurement time for serum and whole blood analysis: Basal, 5 and 10 days. Measurement time for analysis in feces and urine: Basal and after 10 days.	—

Measure

Time frame

Change in blood serum laboratory test values (Na, K, Cl, prothrombin time, partial thromboplastin time, cholesterol, triglycerides, glucose, urea, creatinine, alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, albumin, bilirubin, lactate dehydrogenase biometry), in whole blood (hematic biometry and erythrocyte sedimentation rate), in feces (coproparasitoscopic and stool analysis), and in urine (general urinalysis, protein, creatinine, and Na in a random urine sample). Measurement time for serum and whole blood analysis: Basal, 5 and 10 days. Measurement time for analysis in feces and urine: Basal and after 10 days.

—

Countries

Mexico

Contacts

Public ContactBrenda Paz-Michel

Esteripharma Laboratory

bpaz@esteripharma.com.mx

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 25, 2026