Open-Label, Randomized Controlled Trial Protocol to Evaluate the Efficacy and Safety of Shigru (Moringa oleifera) Leaf Powder as an Add-on to Standard of Care for Glyeemic Control in Patients with Metabolic Syndrome at AIIMS Bhopal
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mean change in Glycemic Markers (HbA1c)
研究概览
简要总结
Metabolic Syndrome is a common health condition where several problems such as high blood sugar, high blood pressure, obesity, and abnormal cholesterol levels occur together. In India, nearly one out of every three people suffers from this condition. It greatly increases the risk of heart disease, stroke, kidney problems, and even early death. Usual treatment includes medicines like metformin and glimepiride (for blood sugar), statins (for cholesterol), and various blood pressure medicines. Although these treatments are effective, many patients still struggle to control their blood sugar and face side effects or long term risks. This makes it important to explore safe and affordable additional options. Moringa oleifera, commonly known as Shigru or the drumstick tree, is a plant widely used in Ayurveda. It is rich in nutrients and has been shown in several studies to help in diabetes, cholesterol problems, and high blood pressure. According to Ayurveda, Shigru is known to reduce Kapha and fat-related disorders, which are closely linked with lifestyle diseases. Modern research suggests that Moringa helps control blood sugar and cholesterol through multiple actions in the body, such as improving insulin sensitivity and reducing inflammation. This study will test whether adding Moringa leaf powder to standard diabetes treatment gives better results compared to standard treatment alone in patients with metabolic syndrome. The study will be conducted at AIIMS Bhopal. A total of 110 patients between 30–65 years of age, diagnosed with metabolic syndrome, will be randomly divided into two groups. Group A (Intervention group) Will receive 12 grams of Moringa leaf powder daily (6 g twice a day) along with standard medicines (Metformin and Glimepiride). Group B (Control group) Will receive only the standard medicines. Both groups will also receive diet and lifestyle counselling, including advice on walking, proper sleep, and avoiding alcohol or tobacco. The study will last for 12 weeks, with check ups at 4, 8, and 12 weeks.
The main measure of success will be improvement in blood sugar control (HbA1c levels). Other outcomes like weight, waist size, blood pressure, cholesterol, liver and kidney health, and any side effects will also be checked.
If Moringa proves effective and safe, it could become a low cost, natural supplement to routine treatment, improving patient outcomes and reducing long-term risks. This may provide a bridge between modern medicine and Ayurveda, offering holistic benefits for people with metabolic syndrome.
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
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 30 to 65 years visiting outpatient department of AIIMS Bhopal Diagnosed with metabolic syndrome and having HbA1C between 6.5 to 8.
- •Patients maintaining stable health conditions and not requiring any acute or long term medication for hypertension, dyslipidemia or obesity management.
- •Willing to comply with protocol and follow up Provide informed written consent.
排除标准
- •Patients receiving oral hypoglycemic medications other than glimepiride or metformin Patients receiving any medications such as antihypertensive, obesity, and hyperlipidemia drugs.
- •Severe Cardiac or hepatic or renal disease Acute cases with Diabetic complications such as ketoacidosis Any malignancy Pregnant or lactating women Allergic to herbal supplements Already using Moringa or any similar herbal interventions Living outside Bhopal.
结局指标
主要结局
Mean change in Glycemic Markers (HbA1c)
时间窗: From baseline (day 0) to | 12 weeks
次要结局
- Fasting Blood Glucose(From baseline (day 0) to)
- Postprandial Blood(Glucose)
- Serum Insulin (HOMA-IR)(From baseline (day 0) to)
- C-peptide(From baseline (day 0) to)
- Weight(From baseline (day 0) to)
- Waist-Hip Ratio(From baseline (day 0) to)
- Systolic and diastolic Blood Pressure(From baseline (day 0) to)
- Lipid Profile(From baseline (day 0) to)
- High-sensitivity C-reactive Protein (hs-CRP)(From baseline (day 0) to)
- Liver(Function Tests)
- Renal Function Tests(From baseline (day 0) to)
研究者
Dr Danish Javed
All India Institute of Medical Sciences Bhopal