Treatment of the hemorrhoidal crisis with recombinant Streptokinase suppositories”.

Center for Genetic Engineering and Biotechnology (CIGB).0 个研究点目标入组 220 人开始时间: 2009年12月11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: Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment

•Fulfillment of the diagnostic criteria (there will be considered eligible all patients of both sexes with a clinical diagnosis of acute hemorrhoids characterized by anal pain of sudden onset, with tumors of variable size and appearance, and may be colored red-violet, usually associated with a significant edema). Aged between 18 and 75 years, inclusive. Voluntary patient signing the informed consent.

•History of intracranial hemorrhage. History of cerebrovascular disease, intracranial surgery or head trauma <3 months. Digestive or urinary bleeding <21 days. Recent surgery <14 days. Recent serious trauma <4 weeks. Puncture of major vessels no compressible in the last 7 days. Treatment with anticoagulant pharmaceuticals. Active internal bleeding (<3 weeks) or other conditions where there is significant risk of bleeding or would be difficult to manage because of its location. History of severe arterial hypertension or ventricular tachycardia. History of hereditary coagulopathy (factor VIII deficiency [classic hemophilia] and IX [Christmas disease] of clotting). Decompensated chronic disease (diabetes mellitus, heart insufficiency, and hyperthyroidism). Peripheral or mesenteric vascular thrombosis. Difficulty in secondary urination due to prostatic hyperplasia. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Acute diarrheal disease in the last 12 hours. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), Phenylephrine, or any ingredient of the formulations under study. Pregnancy or lactation. Obvious mental incapacity to give consent, and act accordingly to the study.

发起方

Center for Genetic Engineering and Biotechnology (CIGB).