A Hybrid Dose-Escalation Randomized Controlled Trial Comparing Unani Drugs and Standard Treatment for Glycemic Control in Type 2 Diabetes Mellitus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Background: Type 2 Diabetes Mellitus (T2DM) is a significant health issue, particularly in India. Standard treatments like metformin and glimepiride are effective but often lead to side effects. Unani formulations, such as Qurs-e-Ziabetus Khaas and Qurs-e-Kafoor, offer a potential alternative due to their hypoglycemic properties
Aim: This study aims to evaluate the efficacy and safety of Unani drugs compared to standard treatments, with the goal of integrating Unani medicine into mainstream diabetes care.
Objective: To compare the efficacy of Unani formulations with standard treatments in controlling blood sugar levels, measured by HbA1c, assess safety, and patient outcomes over a 24-week period.
Methodology: The study is a randomized, controlled clinical trial involving 200 participants with T2DM, randomly assigned to either the Unani treatment group or the standard treatment group. Block randomization with a block size of four will ensure balanced group assignments. Participants in the Unani group will receive Qurs-e-Ziabetus and Qurs-e-Kafoor, while the control group will receive metformin and glimepiride. Both groups will follow standardized diet and exercise plans. The study will follow participants for 24 weeks, with regular follow-up visits every two weeks with dose escalation as per protocol. Inclusion criteria include patients aged 18-65 with HbA1c levels between 7% and 10%, while exclusion criteria involve insulin dependence, severe comorbidities, and pregnancy.
Results: The primary outcome is the change in HbA1c levels measured at baseline, Week 12 and Week 24, providing a direct measure of glycemic control. Secondary outcomes include changes in fasting plasma glucose, lipid profiles, body weight, and patient-reported outcomes including treatment satisfaction and overall wellbeing. Safety assessments, including liver and kidney function tests, will be conducted to monitor adverse events.
Expected Benefits: This study aims to provide robust evidence on the efficacy and safety of Unani formulations in managing T2DM. If successful, the findings could support the inclusion of Unani treatments in national health programs as an alternative for diabetes management. The potential to improve health outcomes could significantly benefit both patients and healthcare systems.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
- •Adults aged 18 to 65 years.
- •Body Mass Index from 18.5 to 35 kg per meter square.
- •Already diagnosed patients with T2DM for up to 10 years.
- •Patients who have not been taking any antidiabetic medication for at least 2 weeks before enrollment.
排除标准
- •Type 1 Diabetes Mellitus or other specific forms of diabetes (e.g., MODY, secondary diabetes).
- •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.
- •Patients currently on insulin therapy.
- •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).
- •Pregnant or lactating women.
- •Conditions such as peptic ulcer disease or severe gastrointestinal disorders that may interfere with treatment.
- •Known allergies or intolerance to metformin, glimepiride, or other study related medications.
- •Patients who are actively taking treatment for T2DM.
结局指标
主要结局
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.
时间窗: HbA1c will be measured at baseline, Week 12, and Week 24 to track changes in glycemic control over time.
次要结局
- 1. Change in Fasting Plasma Glucose (FPG)(2. Time to Achieve Glycemic Targets)
研究者
Dr Nazim Husain
Regional Research Institute of Unani Medicine, Silchar