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. Individuals of any gender identity (male, female, or transgender), aged between 31 to 60 years. 2. Patients with classical signs and symptoms of Madhumeha. 3. Fasting Blood Sugar (FBS) levels between Greater than or equal to 126 mg/dl to less than equal to 180 mg/dl 4. Postprandial Blood Sugar (PPBS) levels between Greater than or equal Greater than or equal 140 mg/dL to less than equal to 240 mg/dL 5. Glycosylated Hemoglobin (HbAlc) levels ranging from greater than equal to 6.5% to less than equal to 9%. 6. Early diagnosed Diabetic patients (Maximum 3 years of diabetic history) 7. Patients willing to participate in the research study 8. Patients who have not taken any conventional( allopathic) antidiabetic medication in the last 3 months before enrollment.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with Type | 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 180 mg/dl and postprandial blood sugar level more than 350 mg/dl or HbAlc more than 9%) 3. Patients with chronic complications related to diabetes, including microvascular (e.g... retinopathy, nephropathy, neuropathy) and macrovascular complications (e.g., coronary artery disease, peripheral vascular disease, cerebrovascular disease). 4. Patients with severe psychiatric illness or cognitive impairment affecting their ability to provide informed consent or follow the study protocol. 5. Pregnant women/lactating mothers. 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 |
|---|---|
| To evaluate the add-on efficacy of Pridhu Nimba Panchaka Ghana capsule 2 (500 mg BD) with Phalatrikadi Ghana capsule 2 (500 mg BD) in comparison to Phalatrikadi Ghana capsule 2 (500 mg HD) alone hy assessing changes in HbAlc levels over 12 weeks in patients with Madhumeha (Type 2 Diabetes Mellitus)Timepoint: To evaluate the add-on efficacy of Pridhu Nimba Panchaka Ghana capsule 2 (500 mg BD) with Phalatrikadi Ghana capsule 2 (500 mg BD) in comparison to Phalatrikadi Ghana capsule 2 (500 mg HD) alone hy assessing changes in HbAlc levels over 12 weeks in patients with Madhumeha (Type 2 Diabetes Mellitus)over 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To assess the reduction in Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) levels. 2. To observe improvement in the clinical signs and symptoms of Madhumeha. 3. To evaluate the improvement in Quality of Life using the SF-36 questionnaire.Timepoint: 1.To assess the reduction in Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) levels. 2. To observe improvement in the clinical signs and symptoms of Madhumeha. 3. To evaluate the improvement in Quality of Life using the SF-36 questionnaire over 12 weeks | — |
Countries
India
Contacts
Public ContactDr Tanvi kashyap
All India Institute of Ayurveda
Outcome results
None listed