THERESA-5 Study

Phase 4

Recruiting

Conditions: Acute hemorrhoids

Registration Number: RPCEC00000191

Lead Sponsor: Center for Genetic Engineering and Biotechnology (CIGB).

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1500

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical response (complete response [no anal pain, rectal bleeding and no reduction of 70% or more of the initial size of the lesion hemorrhoidal] Partial Response [presence of pain and / or rectal bleeding but with reduced level of intensity, and hemorrhoidal lesion reduction of 50-69%]; no Response [no reduction in pain intensity and / or rectal bleeding, and reduction of less than 50% of the lesion hemorrhoidal]) . Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment. <br>Cessation of pain and anal bleeding (Yes, No). Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment.

Secondary Outcome Measures

Name	Time	Method
- Termination of the other clinical manifestations (edema, pruritus, sensation of a mass, tenesmus, constipation, anal burning and diarrhea, among others) (Yes, No). Measuring Time: 48 hours, 4th, 6th and 10th days after the start of treatment. <br>- Need for thrombectomy (Yes, No). Measuring time: 48 hours, 4th, 6th and 10th days after the start of treatment. . <br>- Adverse events (number of events, type, frequency: Yes, No, Intensity: Mild, Moderate, Severe, Severe life-threatening disability and death related adverse event; Duration: hours, days Causation: remote, possible, likely, very likely; Result: Completely resolved, Resolved with sequelae, conditions improved, still present and unchanged conditions, worsening, Death, treatment indicated: type and dosage of medication, treatment time). Measurement time: 48 hours, 4th, 6th and 10th days after the start of treatment.<br>- Presence of anti-streptokinase antibodies (Yes, No). Measuring time: 10 days after starting the treatment.