The Effects of DLBS1033 on Haemostasis Parameters in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

DLBS1033 is bioactive protein fraction which extracted from Lumbricus rubellus earthworm. This earthworm comes from Pengalengan, West Java, Indonesia. DLBS1033 possesses 8 major proteins with molecular weight below 100 kDa, so its named as Lumbricus Low Molecular weight Proteins (LLP). This enzym can be transported to the bloodstream via intestinal epitel. Structure of DLBS1033 looks like lumbrokinase. Lumbrokinase is enzym that consist of 6 isoenzyme serine protease. As a drug that consists of serin protease enzym, suspected that the mechanism of action of DLBS1033 similar with lumbrokinase, especially as plasminogen activator in fibrinolytic system. In vitro study by Trisina et al showed that DLBS1033 has fibrinogenolytic activities on fibrinogen α, beta, and gamma chain, decreasing platelet aggregation and clotting time was prolonged. Until now, the mechanism of action and effects of DLBS1033 on human fibrinolytic and coagulation system still unknown. Therefore, the aim of this clinical trial is to evaluate the effects of DLBS1033 on human fibrinolytic and coagulation system on healthy subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Indonesia University
• Collaborator: Dexa Medica Group
• Treatments: Hemostatics

Criteria

Inclusion Criteria:

• Male

• 18-55 years old

• body mass index between 18-25 kg/square metres

• normal physical examination

• Patient still have the ability to undergo examinations and give written informed consent

• Plasmin-antiplasmin complex (PAP complex) level between 0-514 ng/ml

• Platelet aggregation (ADP 10 uM) > 49%

Exclusion Criteria:

• Patient with cardiovascular disease, hypertension, diabetes mellitus, and dyslipidemia

• Creatinin serum more than 1,5 x upper limit normal

• SGOT and SGPT more than 3 x upper limit normal

• Blood pressure ≥ 140/90 mmHg

• Fasting blood glucose > 126 mg/dL

• Alcohol patients

• Took any medications (including traditional medicine, supplement and vitamin) in 1 week before the study)

• Patient has bleeding history which unclear etiology

• Hemoglobin < 10 g/dL

• Thrombocyte count < 100.000/uL

• Heavy smoker (Bringman Index > 600)