Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
None listed
Sponsors
All India Institute Of Ayurveda
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 31-60 years 2.Patients with classical signs and symptoms of Madhumeha/T2DM 3.Fasting blood sugar (FBS)greater than or equal to 126 mg/dl up to 180 mg/dl and/or 4.Postprandial blood sugar (PPBS) greater than or equal to 200 mg/dl up to 240 mg/dl and 5. Glycosylated haemoglobin (HbA1C) greater than or equal to 6.5% - 9% 6. The patient is willing to give consent. 7. Patient with BMI greater than or equal to 18 to less than or equal to 30 8. Patients diagnosed with Type 2 Diabetes Mellitus within the last 3 years and currently on metformin therapy minimum of under 3 month. . NOTE (In the above-given criteria (3-4), one should be present and raised HbA1C is necessary.)
Exclusion criteria
Exclusion criteria: 1.Patients diagnosed with Type 1 Diabetes Mellitus or those who are insulin-dependent and currently receiving insulin therapy. 2.Patients with uncontrolled hypertension (more than 160/100 mm of Hg), and uncontrolled diabetes (fasting blood sugar level more than 180 mg/dl and postprandial blood sugar level more than 240 mg/dl or HbA1c more than 9% ) 3.Patients with chronic complications related to diabetes, including microvascular (e.g., retinopathy, nephropathy, and neuropathy) and macrovascular complications (e.g., coronary artery disease, peripheral vascular disease, cerebrovascular disease). 4.Pregnant women/lactating mothers. 5.Patient with Hypothyroidism. 6.Patients were reported to be hypersensitive to any of the proposed trial drugs. 7.Participation in other clinical studies in the past 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the add-on efficacy of Nishamalki Ghan Capsule with Metformin compared to Metformin with D4 combination Ghan Capsule by assessing the reduction in HbA1c levels over 12 weeks.Timepoint: Evaluation of the add-on efficacy of Nishamalki Ghan Capsule with Metformin compared to Metformin with D4 combination Ghan Capsule by assessing the reduction in HbA1c levels over 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in classical signs & symptoms like fatigue frequent urination & thirst of Madhumeha Reduction in Fasting Blood Sugar & Postprandial Blood Sugar levels Improvement in Lipid Profile levels & Urine routine & Microscopic Improvement in the quality of life of the patient using the SF 36 fatigue scaleTimepoint: Outcome will be assessed at baseline, 4th week 8th week 12th week & 18th week | — |
Countries
India
Contacts
Public ContactDr Kirti
Outcome results
None listed