Health Condition 1: E115- Type 2 diabetes mellitus with circulatory complications
Conditions
Interventions
None listed
Sponsors
SEIDECOSAA Division of M/s INDIAN SILK FIBRE CO, India
Eligibility
Inclusion criteria
Inclusion criteria: Subjects, aged 18 years and above. Subjects diagnosed with Diabetes with hypertension and hyperlipidaemia, (newly diagnosed and patients who are on treatment).
Exclusion criteria
Exclusion criteria: 1. Subjects presenting with any other life threatening co morbid disease conditions like renal failure, liver failure or severe heart failure. 2. Participation in any other clinical study or test panel within the one month prior to entry into the study. 3. History of allergy to test product 4. History of HIV, HBV, Malignancy, alcohol or drug abuse. 5. Pregnant or lactating subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Polyphagia, Polyurea, Polydipsia, Fatigue, weight loss and Blur vision (if any) â?¢Fasting blood glucose, Post prandial blood glucose and HbA1c levels â?¢Improvement of Systolic and Diastolic blood pressure â?¢Lowering of LDL/VLDL/TG and increase in HDL â?¢Number of Cardiovascular events (myocardial infarction/ stroke) during the study period. â?¢Improvement of Inflammatory markers like ESR and CRP. Timepoint: 4th 8th and 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Patient and investigator feedbacks and Quality of Life will be assessed â?¢ Adverse event monitoring (Laboratory data will be compared Pre and Post study to monitor for the safety of the subjects). Timepoint: 4th 8th and 12th week | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
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Outcome results
None listed