Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Nattokinase: Nattokinase is an enzyme extracted from an ancient Japanese food called Natto. Natto is boiled and fermented soyabeans. Nattokinase is fibrinolytic enzyme and closely resem
Sponsors
Dr Debananda Sahoo
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female aged 40-65 years. 2. Subjects diagnosed with Type II Diabetes minimum of 5 years ago. 3. Subjects stable on Oral Hypoglycaemic Agents. 4. Subjects willing to give written informed consent. 5. Hypertriglyceridemia 6. Subjects with fasting blood glucose 7. Subjects with HbA1c 8. Subjects with BMI 18.5-30 9. Subjects who will be able to travel to the research site without being non-compliant with the visits and procedures.
Exclusion criteria
Exclusion criteria: 1. Subject suffering with serious systemic diseases. 2. Pregnant or lactating women or women having oral contraceptive measures. 3. Subjects taking any anti-coagulative and anti-platelet drugs. 4. Subjects hospitalized 30 days prior to enrolment. (hospitalisation for Any surgery will be excluded?) 5. Subject treated with the following medications: a. Antibiotics within one week prior to study commencement. b. Oral vaccination with biologics within 4 weeks prior to study commencement. c. Previous immunosuppressive or immunostimulant therapy within 3 months prior to study commencement. d. Treatment with corticosteroids. e. Concomitant treatment with Nattokinase within 1 month prior to study commencement. 6. Subjects participating in another clinical trial within 3 months prior to study commencement. 7. Subject with a known allergy or previous intolerance to the other medications. 8. Subjects with Systolic BP of more than 140 mm HG and Diastolic BP of more than 90 mm Hg. (Stage II Hypertensives may be excluded). 9. Diabetic Subjects with severe cardiac conditions/stroke 10. Immunocompromised and Cancer patients 11. Febrile patients 12. Diabetics, already suffering from severe Retinopathy, Severe nephropathy and Diabetic Foot ulcer (DFU). 13. People taking blood thinners like Coumadin and Warfarin or any other anti-platelets and anti-coagulants as per the PIL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Enhanced Fibrinolytic activity and blood flow in Subjects with Diabetes Type II at the end of 6 months from baselineTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in blood viscosity and endothelial function in Subjects with Diabetes Type II at the end of 6 months from baseline.Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactSubham Dutta
Zytex Biotech Private Limited
Outcome results
None listed