Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
DrKirti Satish Pawar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged between eighteen and sixty-five years. 2. Individuals diagnosed with Type Two Diabetes Mellitus, Prediabetes, or Overweight or Obesity with Body Mass Index greater than twenty-five. 3. Willingness to adhere to the study protocol. 4. Ability to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Individuals with Type One Diabetes Mellitus. 2. Pregnant or lactating women. 3. Patients with severe uncontrolled renal, hepatic, or cardiovascular disorders. 4. Known allergy or hypersensitivity to any component of the study lozenges. 5. Participants currently enrolled in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c (%) in diabetic patients (Subgroup A1 vs A2) Change in Fasting Blood Sugar (FBS) in diabetic patients Change in Postprandial Blood Sugar (PPBS) in diabetic patients Percentage of prediabetic participants progressing to diabetes Change in body weight in obese participants Change in Body Mass Index (BMI) and waist circumference in obese participantsTimepoint: Baseline Month 3 Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) across all groups Change in lipid profile (LDL, HDL, Triglycerides) Patient-reported improvements in metabolic wellness and quality of life Incidence and nature of adverse events (safety and tolerability of lozenges) Change in body weight and waist circumference in prediabetic and obese participants Assessment of long-term sustainability of metabolic improvementsTimepoint: Baseline Monthly follow-up visits Month 3 Month 6 | — |
Countries
India
Contacts
Public ContactAniket Santosh Hirave
Siddhivinayak pain relief center
Outcome results
None listed