Proctokinasa® in the treatment of acute hemorrhoid. National Pharmacovigilance.

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 1,500 人开始时间: 2015年4月8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: Treatment

•1) Compliance with the diagnostic criteria (fluxion and / or thrombosed hemorrhoid anal pain characterized by sudden onset, with tumors of variable size and appearance and can be red-violet color, usually associated with significant swelling).
•2) Age = 18 years.
•3) Anal pain (of any degree of intensity) and / or bleeding at the time of inclusion in the study. 4) Voluntariness of the patient by signing the informed consent.

•1. Active internal bleeding (<3 weeks) or other conditions where there is risk of major bleeding, or would be unwieldy because of its location.
•2. acute diarrheal disease in the past 12 hours.
•3. History of allergy to streptokinase, thiomersal, salicylates (including aspirin), or any ingredients of the formulations under study.
•4. Pregnancy or lactation at the time of inclusion in the study.
•5. Mental incapacity to give consent clearly and act accordingly to the study.

发起方

Center for Genetic Engineering and Biotechnology (CIGB).