Hemorrhoidal crisis.
Conditions
Interventions
The products under study will be administered, according to the random distribution, by rectal route in the form of suppositories [A) Recombinante Streptokinase suppository 200 000 UI, B) Recombinante
Placebos
suppository of Recombinant Streptokinase
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Ministry of Public Health, CUBA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diagnosis of haemorrhoidal acute illness. Age equal or superior to 18 years. Voluntary patient signing the informed consent.
Exclusion criteria
Exclusion criteria: History of intracranial hemorrhage. History of cerebrovascular disease, intracranial surgery or head trauma 20 seconds or a coagulation time > 10 seconds. 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. Hemorrhoidal disease caused by portal hypertension. Hemorrhoidal disease associated with abscess, fistula or cancer. Hemorrhoidal disease with septic complications or active hemorrhage. Administration of Streptokinase in the preceding 6 months. History of allergy to Streptokinase, Thiomersal or Salicylates (including aspirin), or any ingredient of the formulations under study. Pregnancy or lactation. Obvious mental incapacity to give consent, and act accordingly to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing at the 5th day after starting treatment, according to the following criteria: all patients with Total Response in the evaluation at 5 days, given by the complete disappearance of pain and edema, and the reduction of more than 90% of the initial size of the lesion with neither absence of relapse nor need of thrombectomy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical response at 24 and 72 hours after starting treatment. Edema, the presence or not will assess through direct physical examination (inspection) of the region. Pain, measured by a scale of pain faces (validated) Size of the lesion; it is an indirect measure and more objective of the development of edema; for this the patient will be placed in prone position with exposure of the anal part and will be measured (ruler in millimeters) in centimeters (at the inclusion, 24 horas, and at 3 and 5 days after starting treatment) the largest horizontal and vertical diameters of the lesion. Need to apply surgery. Relapse (at the 5th day and in the consultation for a follow up at 20 days). | — |
Countries
Cuba
Contacts
Public ContactFrancisco Hernández-Bernal
Center for Genetic Engineering and Biotechnology.
Outcome results
None listed