Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Saansure: Saansure is a proprietary oral food supplement formulated with a blend of bioactive natural ingredients that are
traditionally known and scientifically explored for their pote
Sponsors
Saanso Nutri Sciences Private Limited
Saanso Nutri Sciences Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged between 18 and 70 years (inclusive) Clinically confirmed diagnosis of Type 2 Diabetes Mellitus for at least 6 months, in accordance with the American Diabetes Association (ADA) criteria Glycated haemoglobin (HbA1c) levels between 8.0% and 10.0% at the time of screening Stable regimen of oral anti-diabetic medications (e.g., metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists) for at least 3 months prior to screening Body Mass Index (BMI) between 18.5 and 35.0 kg/m Willingness to maintain a consistent diet and physical activity routine throughout the study duration Ability to provide written informed consent and comply with all study-related procedures Laboratory values indicating normal or clinically acceptable liver and renal function female participants women of childbearing potential must agree to use reliable contraception for the duration of the study.
Exclusion criteria
Exclusion criteria: Type 1 diabetes or latent autoimmune diabetes in adults LADA and Use of insulin therapy History of diabetic ketoacidosis or hyperosmolar hyperglycaemic state in the past 6 months Severe diabetic complications e.g., proliferative retinopathy, nephropathy requiring dialysis, foot ulcers History of cardiovascular events MI, stroke, unstable angina in the past 6 months and Heart failure NYHA Class III or IV Uncontrolled hypertension Severe renal impairment Liver disease cirrhosis, hepatitis B or C infection Active malignancy or history of cancer within the past 5 years Diagnosed autoimmune disorders or chronic inflammatory diseases History of alcohol or substance abuse within the past year Known gastrointestinal malabsorption or surgeries affecting absorption e.g., bariatric surgery Pregnant or breastfeeding women Participation in another interventional clinical trial within the past 30 days Use of nutritional supplements aimed at glucose control e.g.cinnamon, berberine, chromium in the past 30 days Known allergy or intolerance to any ingredient in the Saansure supplement History of severe hypersensitivity reactions e.g anaphylaxis Any Chronic Health History
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from Day -1 to Day-90Timepoint: Mean change in HbA1c from Day -1 to Day-90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To Assess safety profile, changes in FBS and PPBS, Fasting Serum Insulin, lipid profile, Renal Function Test, and patient-reported outcomes. To assess the safety and tolerability of Saansure Oral Food Supplement through adverse event (AE) reporting and laboratory parameters. To measure any improvement in patient-reported using Diabetes Treatment Satisfaction Questionnaire and Food Benefit Assessment for Diabetic patientsTimepoint: Day -1 to Day-90 and FBS AND ADDITIONALLY FBS AND PPBS AT DAY 30 | — |
Countries
India
Contacts
Public ContactMr K Gowtham Kumar
Saanso Nutri Sciences Private Limited
Outcome results
None listed