A Comparative Study to evaluate the efficacy of Patha Vidanga Arjuna Dhanvana Kwath with conventional medicine alone in control of “Metabolic Syndrome†in Urban Population of an area in an Urbanised Indian State
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
研究概览
简要总结
The Metabolic Syndrome is a cluster of factors, namely central obesity, glucose intolerance, low amount of High-density lipoprotein (HDL), high triglycerides (TG) and systemic hypertension. It has a high prevalence rate with more than 10 million cases per year In India. In India, recent rise in Metabolic Syndrome has been attributed to the shift in lifestyles, both in the urban and in the rural areas. Metabolic Syndrome has the potential to double the risk of cardiovascular diseases, which is one of the major leading causes of adult death. Metabloic syndrome usually requires a team work of Endocrinologists, Cardologists and Nutritionists. Ayurveda being a Holistic system of Medicine can single handedly handle this complex condition with its Dosha based treatment system. And moreover it directly falls under the category of Sthula Pramehi (Obese Diabetic) which is clearly and elaborately mentioned in our texts along with its management. Thus, Ayurveda already has what it takes to manage Metabolic Syndrome well and that too without inducing any adverse effects of drugs. The Prameha chapter of Chikitsa sthan of Charak Samhita mentions many formulations for the management of different types of Prameha’s. For the management of Kaphaj Prameha there is a mention of 10 kwath formulations: हयीतकीकटà¥à¤ªà¤°à¤à¥à¤¸à¥à¤¤à¤°à¥‹à¤§à¥à¤°à¤‚ ऩाठाविडङà¥à¤—ारà¥à¥à¥à¤¨à¤§à¤¨à¥à¤¿à¤¨à¤¾à¤¶à¥à¤š| उबे हरयदà¥à¤°à¥‡ तगयं विडङà¥à¤—ं कदमà¥à¤«à¤¶à¤¾à¤°à¤¾à¤°à¥à¥à¥à¤¨à¤¦à¥€à¤ªà¥à¤®à¤•à¤¾à¤¶à¥à¤š||२à¥|| दािी विडङà¥à¤—ं खददयो धिशà¥à¤š सà¥à¤¯à¤¾à¤¹à¥à¤µà¤•à¥ô€†µà¤¾à¤—à¥à¤°à¥à¤šà¤¨à¥à¤¦à¤¨à¤¾à¤¨à¤¨| दारà¥à¤µà¤®à¥à¤—à¥à¤¨à¤¨à¤à¤¨à¥à¤¥à¥Œ विपरा सऩाठा ऩाठा च à¤à¥‚िाॠच तथा शà¥à¤µà¤¦à¤‚षà¥à¤Ÿà¤¾||२८|| मिानà¥à¤®à¥à¤¶à¥€à¤¯à¤¾à¤£à¥à¤®à¤¬à¤®à¤¾à¤—à¥à¤¡à¥‚चीचरà¥à¤µà¤®à¤¾à¤¬à¤®à¤¾à¤¨à¤šà¤¿à¤•à¤¸à¤ªà¥à¤¤à¤©à¤°à¤¾à¥à¥| ऩाद ॠकषामाॠकपà¤à¥‡à¤¦à¤¹à¤¨à¤¾à¤‚ ते दशोऩददô€†´à¤¾ à¤à¤§à¥à¤¸à¤®à¥à¤°à¤®à¥à¤•à¥à¤¾à¥||२९|| We will use one of these formulations, which has a combination of Patha (Cissampelos pareira), Vidang (Embelia ribes), Arjuna (Terminalia arjuna) and Dhanvana (Grewia tiliaefolia) for our research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •o Age 40-65 Yrs.
- •o Patients with Metabolic syndrome according to NCEP ATP3 Criteria.
排除标准
- •Age <40yrs.
- •With associated heart disease or other secondary complications.
结局指标
主要结局
Fasting plasma glucose ≥ 6.1 mmol/L (110 mg/dl)
时间窗: At the end of 30 days, 60 days and 90 Days.
Reduction in following criteria which are base for diagnosis of Metabolic Disorder:
时间窗: At the end of 30 days, 60 days and 90 Days.
Blood pressure ≥ 130/85 mmHg (or treated for hypertension)
时间窗: At the end of 30 days, 60 days and 90 Days.
Central obesity: Waist circumference ≥ 102 cm or 40 inches (male), ≥ 88 cm or 35 inches(female)
时间窗: At the end of 30 days, 60 days and 90 Days.
TG ≥ 1.7 mmol/L (150 mg/dl)
时间窗: At the end of 30 days, 60 days and 90 Days.
HDL-C 40 mg/dL (male), 50 mg/dL (female)
时间窗: At the end of 30 days, 60 days and 90 Days.
次要结局
- Improvement in Quality of life:(Based on the signs & symptoms reported by the patients before and after treatment, relief in mental & physical health will be accessed on the basis of grading developed for these clinical factors and it will be followed by statistical analysis.)