Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
Central Council For Research In Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India
Eligibility
Inclusion criteria
Inclusion criteria: Known participants of Type 2 diabetes mellitus having HbA1C greater than or equal to 6.5 percent with established clinical diagnosis of type 2 DM for at least 3 months prior to the screening period and are on Oral Hypoglycemic drugs Stable Hypertensive participants on antihypertensive medication
Exclusion criteria
Exclusion criteria: Participants with type 1 diabetes mellitus Participants being treated for DM type 2 with insulin Participants with the severe complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, diabetic microangiopathy etc. Known cases of hypothyroidism with thyroid stimulating hormone (TSH) levels not within normal range (based on reference laboratory values) Participants with history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months Symptomatic patient with clinical evidence of Heart failure Participants with concurrent serious Hepatic Dysfunction (defined as AST and or ALT more than 3 times of the upper normal limit) or Renal Dysfunction (defined by eGFR more than 60 ml per minute calculated by MDRD eGFR calculator), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) or other concurrent severe disease. Pregnant Lactating women or intent to become pregnant during the study period Participants on steroids, oral contraceptive pills or estrogens replacement therapy Alcoholics and/or drug abusers Participants with evidence of malignancy Participants suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, Known (or evidence of) infection with human immunodeficiency virus etc.) History of hypersensitivity to any of the trial drugs Participants who have completed participation in any other clinical trial during the past three months Participants not able to provide written informed consent Any other condition which the Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean value of HbA1c from baseline to the end of treatmentTimepoint: Baseline, 90 days and 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Fasting glucose level Change in HOMA IR Homeostatic Model Assessment of Insulin Resistance score and HOMA B Homeostasis Model Assessment of Beta-cell function score from baseline Percentage of participants with changed dose of Oral hypoglycaemic Drugs Change in Lipid profile from baseline to the end of treatment Change in SF 36 RAND Health Survey Score Tolerability to Ayush D through reported incidence of treatment-emergent adverse events and serious adverse events Treatment adherence through self-reported compliance log and used medication containers or strips Change in total treatment satisfaction score of Diabetes Treatment Satisfaction Questionnaire Change in laboratory safety parameters like LFT KFT CBC Lipid Profile from baselineTimepoint: Baseline 30 60 90 120 150 and 180 days | — |
Countries
India
Contacts
Public ContactDr Srinibash Sahoo
Central Ayurveda Research Institute (CARI), under CCRAS, Ministry of Ayush, Govt. of India
Outcome results
None listed