Healthy Clinical Trial
Official title:
The Effects of DLBS1033 on Haemostasis Parameters in Healthy Volunteers
Verified date | May 2017 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | December 2012 |
Est. primary completion date | October 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Indonesia | Indonesia University | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Dexa Medica Group |
Indonesia,
Jin L, Jin H, Zhang G, Xu G. Changes in coagulation and tissue plasminogen activator after the treatment of cerebral infarction with lumbrokinase. Clin Hemorheol Microcirc. 2000;23(2-4):213-8. — View Citation
Kasim M, Kiat AA, Rohman MS, Hanifah Y, Kiat H. Improved myocardial perfusion in stable angina pectoris by oral lumbrokinase: a pilot study. J Altern Complement Med. 2009 May;15(5):539-44. doi: 10.1089/acm.2008.0506. — View Citation
Kim YS, Pyo MK, Park KM, Hahn BS, Yang KY, Yun-Choi HS. Dose dependency of earthworm powder on antithrombotic and fibrinolytic effects. Arch Pharm Res. 1998 Aug;21(4):374-7. — View Citation
Lee CK, Shin JS, Kim BS, Cho IH, Kim YS, Lee EB. Antithrombotic effects by oral administration of novel proteinase fraction from earthworm Eisenia andrei on venous thrombosis model in rats. Arch Pharm Res. 2007 Apr;30(4):475-80. — View Citation
Mihara H, Sumi H, Yoneta T, Mizumoto H, Ikeda R, Seiki M, Maruyama M. A novel fibrinolytic enzyme extracted from the earthworm, Lumbricus rubellus. Jpn J Physiol. 1991;41(3):461-72. — View Citation
Rey I. Pengaruh pemberian lumbrokinase selama 7 hari terhadap status hiperkoagulasi pada penderita ulkus kaki diabetik. Tugas Akhir Dalam Rangka menyelesaikan Pendidikan Dokter Spesialis Ilmu Penyakit Dalam. FK-USU, Medan. 2009.
Schmaier AH, Thornburg CD, Pipe SW. Coagulation and Fibrinolysis. In: McPherson RA, Pincus MR, editor. Henry's Clinical Diagnosis and Management by Laboratory Methods. 21st ed. Philadelphia: Saunders Elsevier; 2007. p. 731-3.
Trisina J, Sunardi F, Suhartono MT, Tjandrawinata RR. DLBS1033, a protein extract from Lumbricus rubellus, possesses antithrombotic and thrombolytic activities. J Biomed Biotechnol. 2011;2011:519652. doi: 10.1155/2011/519652. Epub 2011 Mar 3. — View Citation
Yan XM, Kim CH, Lee CK, Shin JS, Cho IH, Sohn UD. Intestinal Absorption of Fibrinolytic and Proteolytic Lumbrokinase Extracted from Earthworm, Eisenia andrei. Korean J Physiol Pharmacol. 2010 Apr;14(2):71-5. doi: 10.4196/kjpp.2010.14.2.71. Epub 2010 Apr 30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | serum creatinine | serum creatinine | one week | |
Other | serum glutamic oxaloacetic transaminase (SGOT) | changes in serum glutamic oxaloacetic transaminase | one week | |
Other | serum glutamic pyruvic transaminase (SGPT) | changes in serum glutamic pyruvic transminase | one week | |
Primary | plasmin-antiplasmin complex (PAP complex) | changes in plasmin-antiplasmin complex | one week | |
Secondary | euglobulin clot lysis time (ECLT) | changes in euglobulin clot lysis time | one week | |
Secondary | prothrombin time (PT) | changes in prothrombin time | one week | |
Secondary | fibrinogen | changes in fibrinogen | one week | |
Secondary | activated partial thromboplastin time (aPTT) | changes in activated partial thromboplastin time | one week | |
Secondary | platelet aggregation | changes in platelet aggregation | one week |
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