Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Qurs-e-Ziabetus Khaas and Qurs-e-Kafoor: 1. Qurs-e-Ziabetus Khaas:
o Dosage: The initial dosage will be 1g twice daily (BID). Based on the patients glycemic response, the dose may be es
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Regional Research Institute of Unani Medicine Silchar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Type 2 Diabetes Mellitus (T2DM): Patients with a confirmed diagnosis of T2DM based on American Diabetes Association (ADA) or World Health Organization criteria. Diagnostic criteria include: HbA1c more than or equal to 6.5, or fasting plasma glucose, more than or equal to 126 mg per dL (7.0 mmol per L), or 2 hour plasma glucose more than or equal to200 mg per dL (11.1 mmol per L) during an Oral Glucose Tolerance Test. 2. HbA1c more than 6.5 to less than or equal to 9 or blood glucose more than or equal to 126 mg per dL (7.0 mmol per L) to less than or equal to 300 mg per dL (less than or equal to 16.7 mmol per L), indicating suboptimal glycemic control, and a need for additional therapeutic intervention. 3. Adults aged 18 to 65 years. 4. Body Mass Index from 18.5 to 35 kg per meter square. 5. Already diagnosed patients with T2DM for up to 10 years. 6. Patients who have not been taking any antidiabetic medication for at least 2 weeks before enrollment.
Exclusion criteria
Exclusion criteria: 1. Type 1 Diabetes Mellitus or other specific forms of diabetes (e.g., MODY, secondary diabetes). 2. Severe Diabetes Complications: Advanced diabetic neuropathy, nephropathy, or retinopathy. History of recent cardiovascular events, such as myocardial infarction or stroke within the past 6 months. Active or unstable diabetic foot ulcers or severe peripheral vascular disease. 3. Patients currently on insulin therapy. 4. Significant liver disease, renal insufficiency (e.g., estimated glomerular filtration rate less than 30 mL per min per 1.73 meter square), or heart failure (NYHA class III to IV). 5. Pregnant or lactating women. 6. Conditions such as peptic ulcer disease or severe gastrointestinal disorders that may interfere with treatment. 7. Known allergies or intolerance to metformin, glimepiride, or other study related medications. 8. Patients who are actively taking treatment for T2DM.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c: The primary measure of efficacy will be the change in HbA1c levels from baseline to Week 24. HbA1c is a key indicator of long-term glycemic control and will be used to assess the overall effectiveness of the treatments in reducing blood glucose levels.Timepoint: HbA1c will be measured at baseline, Week 12, and Week 24 to track changes in glycemic control over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Fasting Plasma Glucose (FPG) 2. Time to Achieve Glycemic Targets 3. Change in Body Mass Index (BMI) 4. Change in Lipid Profile: 5. Change in Clinical Symptoms: The severity of classical symptoms, including polydipsia, polyuria, polyphagia, fatigue, and sleep disturbances, will be assessed using a 5-point Likert scale to evaluate the treatment impact on clinical symptoms. 6. Treatment Satisfaction and Well-being: Patient satisfaction with the treatment and overall well-being will be measured using a 10-point Visual Analog Scale (VAS). Timepoint: -Change in Fasting Plasma Glucose (FPG) Time Points: FPG will be assessed at baseline and at every follow-up visit (every 2 weeks). -Time to Achieve Glycemic Targets Time Points: This will be tracked at each follow-up visit. -Change in Body Mass Index (BMI) Time Points- Body weight will be measured at baseline, Week 12, and Week 24. -Change in Lipid Profile: Time Points- Lipid profile will be assessed at baseline, Week 12, and Week 24. -Change in Clinical Symptoms: The severity of classical symptoms, including polydipsia, polyuria, polyphagia, fatigue, and sleep disturbances, will be assessed using a 5-point Likert scale to evaluate the treatment impact on clinical symptoms. Time Points- Body weight will be measured at baseline, Week 12, and Week 24. -Treatment Satisfaction and Well-being: Patient satisfaction with the treatment and overall well-being will be measured using a 10-point Visual Analog Scale (VAS). Time Points- Body weight will be measured at baseline, Week 12, and Week 24. | — |
Countries
India
Contacts
Public ContactDr Nazim Husain
National Research Institute of Unani Medicine for Skin Disorders
Outcome results
None listed