Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Glysikot granule 5g oral dose tid for 6 months: Each 5 g granule contains,
Amrita (Tinospora cordifolia) 0.416 g
Abhaya(Terminalia chebula) 0.416 g
Dhatri(Phyllanthus
Sponsors
Clinfound Clinical Research Services P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients between 30-60 age, both sex. 2.Body mass index (BMI) below 40 kg/m². Group A. 1.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 Metformin alone 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.Under 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 >1.4 mg/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, Psycho-Neuro- Endocrinal disorders, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percentTimepoint: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 24 (End of study). HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Change from Baseline in Fasting Plasma Glucose (FPG) to Week 24 â?¢Change from Baseline in 2-hr Post-Meal Glucose (PMG) to Week 24 â?¢Changes from Baseline in Lipid Profile to Week 24 â?¢Changes from Baseline in BMI to Week 24 â?¢Symptomatic changes assessed using Ayurvedic symptom questionnaire from Baseline to week 24 to assess changes in quality of life. Timepoint: Week 0 to Week 24 | — |
Countries
India
Contacts
Public ContactDr Sreejith Sreekumar
Clinfound Clinical Research Services (P) Ltd
Outcome results
None listed