PSP- Classic

Fibrin filaments wrap around and entrap a single red blood cell.

The beginning of a blood clot:  Platelet and Red blood cells become trapped in a network of fibrin cables.

A floating time bomb,  an emboli could be trapped and blocking artery at any time.

In vitro   Thrombolysis comparison  between  M-boless and Urokinase 

(Urokinase is current standard treatment in hospitals,  I.V. only)

In vitro artificial embolus at approx. 40 mg each;  Placed in 37^o C;  rotate at 9 rpm.

6000 unit/kg

Test 1:

40 mouse at body weight between 18-20 gram, 20 are male, 20 are female, divided into mixture genders of  4 groups.  I.V. injection of M-boless for 7 days. The test determined  LD₅₀=144000 unit/kg.

Test 2:

80 Wister mouse,  bodyweight between 160 to 250 gram, 50% in each gender, divided into mixture of 4 groups,  three groups receive  I.M. injection of 25% of LD₅₀  dosage and 10% of  LD₅₀  dosage, once a day, for two weeks. Control group of 20 mouse are injected with saline.

Measurement of GPT, BUN and Hematocrit and platelets count show no change in either groups, indicates no kidney or liver damage was induced.

Test 3:

12 Dogs, bodyweight between 10 to 17 kg.  50% gender each, divided into mixture gender of 3 groups.  Two groups receives I.V. injection of 12.5% of LD₅₀ dosage and 20% of  LD₅₀ dosage, once a day, for two weeks; Control groups received saline injection.  Group I, II receive 12.5% and 20% of  LD₅₀ dosage, experience lost control of urinary, and bowel movement, vomiting, drowsiness, salivation, lost of balance  with in one hour immediate after the injection, symptom subsided after one hour after injection.  Group III does not show any symptom, as the control group.

Summary of Phase I  M-boless capsule clinical trail 

M-boless clinical test Phase 1,  15 healthy volunteers. 

1. Single and multiple oral intakes of M-boless, No adverse effect noticed.
2. Single and multiple oral intakes of M-boless, No adverse effect to Liver, Kidney functions, No adverse effect on  blood sugar level, No adverse effect on blood lipid level.
3. Single and multiple oral intakes of M-boless, Fibrinolytic and U-globulin dissolving time is shortened; No effect on  Bleeding time and Coagulation time.

Summary of Phase II  M-boless capsule clinical trail 

1990 to 1991 total of 453 cases of cerebra-thrombosis were treated, 303 cases were given M-boless, 150 cases were give placeboes, two capsules each time, three times per day,  for 21 days.

All 453 patients suffered from Carotid artery thrombosis, with various degree of impair control of extremity with confirmation by CT of thrombosis blockage.      

Comparison of Pre and Post treatment of Blood pictures and Globulin dissolving time.

Discussion:  Post treatment shows improvement in  Fibrinogen volume, Globulin dissolve time, Viscosity of blood, Plasma viscosity, Hematocrit, and Platelet aggregation. 

The amount of improvement is determined by the schedules of  Clinical neurological damage classification  1-15  ( light),  16-30 (mid),  31-45 (heavy).

Conclusion: M-boless its total effective at 93.7%, noticeable effective at 73.6%.

Conclusion:

Under the supervision of Health Department, at the specified locations, Phase 1 and Phase 2 clinical tests have proven that oral capsule of M-boless for three weeks have remarkable effect for the condition of  Ischemic cerebrovascular disease, paralysis caused by stroke (CVA),  and lost of speech and limbs functions from the result of stroke.

There is no adverse effect to liver function, kidney function, blood sugar level, blood lipid level. It is a safe potential fibrinolytic agent.

Also during the test period, we notice patient’s fibrinogen level reduced to normal level, EU-globulin lysis time (ELT)  has shortened, whole blood viscosity and plasma viscosity are noticeable reduced,  and reduce the platelet aggregation tendency which indicates oral intakes of M-boless is beneficial to avoid heart and cerebral disease for the patients who are in high risk of.

M-boless capsules, its effectiveness is noticeable, no toxic side effects, it is in oral format easy and convenient to use. Suitable to use in the prevention of any of embolism or any of the blood thrombosis type of disorder.  For Acute stroke, lost of speech function  and limb paralysis due to stroke have very noticeable effect.  It is very suitable and potential to use it in prevention of heart and cerebral vascular disorders.

M-boless is not only for therapeutic, it is also an idea agent for prevention.

Summary of Phase III  M-boless capsule clinical trail 

CVA Cerebral Vascular Accident is a very frequent brain vascular disorder. Its onset fast,  causes damage severely, it seriously affect patients’ quality of life. Although, there are many treatments available for this type of disorder,  yet none of  any oral  medication provides such effective results.   M-boless is formulated by chelating several micro-organism produced enzymes, they are mainly to activate Plasminogen, and plasmin.

In 1990 phase II study of 450 plus patients, under double blind, random test, proves that M-boless has 93.7% effective rate in the treatment of Ischemic brain vascular disorder.  To be further verify the efficacy and if any possible adverse effect of the formula.  We have organized these 16 hospitals under the guide line of  health department new drug application to conduct this phase III study. 

In 1992 to 1993  total of 16 hospitals and 1560 cases participated.

Total effective rate  88.21%,    Noticeable effective rate  68.91%

Recommended dosage:  2 caps. each time,  three times per day,  take it 30 minutes before meals.    20 days as a treatment cycle.  Use 1, 2, or 3 cycles or until the disappearance of the symptoms. 

Medical monitoring of  Hematocrit, platelet count, activated partial thromboplastin time, or prothrombin time is advised.

Cautious should be given to patients with active internal bleeding, history of cerebrovascular accident, recent (within 2 months) intracranial or intraspinal surgery, intracranial neoplasm, Arteriovenous malformation or aneurysm, known bleeding diathesis,  and uncontrolled arterial hypertension. 

Although hemorrhagic strokes are far less common, (occur when an artery bursts), care should be given to differentiate  the type and the cause of the strokes and the timing of using M-boless.  For example to use it after the hemorrhaging is over, and no further bleeding is anticipated.