Health Condition 1: E119- Type 2 diabetes mellitus without complications Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Pramehoushadhi Tablet alone
2 tablets twice daily before food for 3 months: Pramehoushadhi tablet is a tablet formulation of Oushadhi - The Pharmaceutical Corporation (I.M) Ltd,Thrissur
Sponsors
Clinfound Clinical Research Services Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients between 30-65 age, both sex. 2.Body mass index (BMI) below 40 kg/m². Group A 1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment. 2.Hemoglobin A1c (HbA1c) >=7.5% and 3.Fasting Plasma Glucose (FPG) >=130 mg/dL Group B. 1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control. 2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and =130 mg/dL
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes. 2.Current need for Insulin treatment. 3.Complication of DM. 4.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 > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 5.Women who are pregnant or lactating 6.Smokers/Alcoholics and/or drug abusers 7.Patient with poorly controlled Hypertension 8.Patients with evidence of malignancy 9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study).Timepoint: Visit 1(Day 1) and Visit 12(Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| Body Mass Index and Blood PressureTimepoint: Visit 1, Week 2,Week 4, Week 6,Week 8, Week 10, Week 12;Change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 12Timepoint: Visit 1,Week 2,Week 4,Week 6, Week 8,Week 10, Week 12;Change from Baseline in Fasting Plasma Glucose (FPG) to Week 12 Timepoint: Vist 1, Week2,Week4,Week 6, Week 8,Week 10,Week 12;Symptomatic changes assessed using Ayurvedic symptom questionnaire from Baseline to week 12 to assess changes in quality of life. Timepoint: Visit 1,Week 2,Week 4,Week 6,Week 8, Week 10, Week 12 | — |
Countries
India
Contacts
Public ContactDrSreejith Sreekumar
Oushadhi The Pharmaceutical Corporation (I.M) Ltd
Outcome results
None listed