Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Male or female aged between 30 to 65 years HbA1c between 7 percent and 10 percent Diagnosed with T2DM for at least 6 months Able to provide informed consent
Exclusion criteria
Exclusion criteria: Type 1 diabetes or acute complications including DKA and HHS Uncontrolled hypertension more than or equal to 160 and 100 mmHg Recent cardiovascular events in last 6 months Severe liver or kidney dysfunction On anticoagulants Active infection or malignancy or autoimmune disease Pregnant or lactating women Allergy to Sea Buckthorn
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c levels from baseline to Week 12Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in fasting blood glucose (FBG)Timepoint: 12 weeks;Change in body weight, BMI, waist and hip circumferenceTimepoint: 12 weeks;Change in lipid profile (Total cholesterol, LDL-C, HDL-C, triglycerides)Timepoint: 12 weeks | — |
Countries
India
Contacts
Mediception Science Pvt Ltd