Clinical study to evaluate the Efficacy of Nattokinase as a Nutraceutical supplement for preventing blood clot in Type II Diabetes Mellitus Patients.

Not Applicable

• Conditions: Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

• Registration Number: CTRI/2019/10/021808
• Lead Sponsor: Dr Debananda Sahoo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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 <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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified