A prospective open label non-comparative clinical study to evaluate the Efficacy of Nattokinase as a Nutraceutical supplement for preventing Thrombosis in Subjects with Type II Diabetes Mellitus Patients.

Dr Debananda Sahoo0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 <130 mg/dl
•7. Subjects with HbA1c <7% (8.6 mmol/mol), ( <154mg/dl)
•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.

•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.

发起方

Dr Debananda Sahoo