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

Esteripharma Laboratory0 个研究点目标入组 30 人开始时间: 2023年7月21日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Other

•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.

•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.

发起方

Esteripharma Laboratory