Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications
Conditions
Interventions
Intervention1: Diabetic Support Product (GP/PROD/2021/001): 2 tablets twice a day after meals for 3 months
Control Intervention1: Placebo tablets: 2 tablets twice a day after meals for 3 months
Sponsors
Mr Kamlesh Thummar
Mr Pritesh Shah
Eligibility
Inclusion criteria
Inclusion criteria: Patients between 30-70 (both inclusive) age both sex Patients receiving standard treatment for Type 2 Diabetes Mellitus Hemoglobin A1c (HbA1c) >6.5 % and Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)
Exclusion criteria
Exclusion criteria: Type 1 diabetes under Insulin treatment Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT >3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or another concurrent severe disease. Women who are pregnant or lactating Smokers/Alcoholics and/or drug abusers Patients with evidence of malignancy Patients suffering from major systemic illness necessitating long-term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fasting and postprandial Blood Glucose. Change in Fasting and post meal insulin levels. Change in HbA1c levels.Timepoint: Screening Day, Baseline Day, Day 30 , Day 60 , Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes of the b-cell functions (homeostasis model assessment [HOMA]-b, insulin resistance (IR) by HOMA- IR To evaluate changes in anthropometric parameter like Body weight and BMI Improvement in the clinical symptoms, i.e., Polyurea, Polyphagia, Polydypsia and Fatigue associated with type 2 DM. Changes in Quality of Life scoreTimepoint: Screening to end of the study | — |
Countries
India
Contacts
Public ContactMr Chetan savaliya
Gplife Healthcare Pvt Ltd
Outcome results
None listed