None listed
Conditions
Interventions
Intervention1: PFP: 220mg for 4months
Control Intervention1: Placebo: 220 mg (4 months)
Sponsors
South West Scientific Editing and Consulting / Kemin Foods
4703 N. City View Drive, Tucson
AZ, 85749
USA
Sugen Life Sciences
No.4/86 S.V. Nagar
Perumalla Palle Post
Tirupati-517 505.
Eligibility
Inclusion criteria
Inclusion criteria: ? Diagnosed with type-2 diabetes in the age group of 30-70 years ? Blood pressure: systolic >140 and diastolic >90 mmHg ? Subjects whose fasting blood glucose levels with above 140 mg/dl and normal in other biochemical parameters ? Taking standard medication for the last three months ? Individual as well as family history of diabetes and obesity ? Willing to sign the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: ? Diabetic patients currently under treatment for heart disease, cancer, post-surgical patients, tuberculosis and other chronic diseases. ? Subjects who are bedridden for chronic diseases for prolonged time and kidney diseases and whose serum creatinine levels are >1.5 mg/dl ? Chronic chewers and usage of drugs ? Diabetes patients taking insulin (type-1 diabetes patients) ? Subjects who had cancer, AIDS, HIV, heart failure, major surgery in past 4 years ? Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variables will be PFP formulation induced changes in blood pressure, heart rate, fasting and post-prandial glucose, total cholesterol and triglycerides.Timepoint: | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy variables include: ? Changes in serum concentrations of LDL-cholesterol, HDL-cholesterol and hemoglobin A1c. ? Changes in body weight and BMI. ? Incidence and severity of adverse events Timepoint: | — |
Countries
India
Contacts
Public ContactI.Nagaraju
Sugen Life Sciences Pvt Ltd
Outcome results
None listed