Health Condition 1: null- Patients with Type 2 Diabetes Melitus who are drug naive and on adjuant medication Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: DiaDropsz Arka alone: 30 drops thrice daily after food for 3 months.DiaDropsz is an arka proparation
Control Intervention1: Oral Hypoglycemic Agent with DiaDropsz Arka: DiaDropsz arka
Sponsors
Clinfound Clinical Research Services PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.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: Baseline and Week 12 (End of study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in 2-hr Post-Meal Glucose (PMG)Timepoint: Baseline Day 10 Day 20 Day 30 Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study);Change from Baseline in Fasting Plasma Glucose (FPG)Timepoint: Baseline Day 10 Day 20 Day 30 Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study);Changes from Baseline in BMITimepoint: Baseline Day 10 Day 20 Day 30 Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study;Symptomatic changes assessed using Ayurvedic symptom questionnaireTimepoint: Baseline Day 10 Day 20 Day 30 Day 40 Day 50 Day 60 Day 70 Day 80 Day 90(End of Study) | — |
Countries
India
Contacts
Public ContactDr Sreejith Sreekumar
Clinfound Clinical Research Services Pvt Ltd
Outcome results
None listed