Comparative study to evaluate the efficacy of Bhumyamalaki Swarasa and Nisha Amalaki Churna in the management of Metabolic Syndrome w.s.r. Medodushti- A randomized controlled open clinical trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Reduction in HOMA-IR Score
研究概览
简要总结
Meda is one of the seven dhatus present in the body. The term Medodushti comprises of two terms Medas ( Sneha of body) and Dushti ( Vitiation from its normal physiology). Medodushti is defined as vitiation in Prakrit KaryaofMedo Dhatu. According toAcharya Charaka NidanaofMedovaha Strotodushtiare non exercise, sleep during day time, excess intake of oily and fatty substances in the diet, drinking of alcoholic drinks. The person with Medodushti will have Kshudra Shwas (breathlessness), Trishna (increased thirst), Daurgandhya (bad smell of body),Kshudha Atimatra (Excessive hunger), Nidradhikya (Excessive sleep), Swedadhikya (Excessive sweating),Alpa Prana (fatigue). Medodushti is well corelated with Metabolic Syndrome. Insulin resistance is a characteristic feature of type 2 Diabetes and is central to the diagnosis of Metabolic Syndrome, which encompasses the different clinical abnormalities and tends to congregate in patients with Insulin resistance, Hypertension, Central obesity, Lipid abnormalities and Prothrombotic state. According to NCEP ATP III definition, Metabolic Syndrome is present if three or more of the following five criteria are met -
Waist circumference over 40 inches (men) or 35 inches (women) , Blood Pressure over 130/85 mm of Hg , Fasting Triglyeceride level over 150 mg/dl , Fasting High Density Lipoprotein (HDL) Cholesterol level less than 40 mg/dl (men) or 50mg/dl (women) and Fasting Blood Sugar level over 100 mg/dl. The Prevalence of Metabolic Syndrome is significant in men (54.8%) compared to women (45.2%). Patients in the age group 51-60 years were found to be more affected with Metabolic Syndrome.
The present study aims to evaluate the comparative effect of Bhumyamalaki SwarasaandNisha Amalaki Churna in the management of Metabolic Syndrome ~ Medodushti.
The total number of patients is 52, 26 in each group.
In group A, Bhumyamalaki Swarasa will be administered in a dose of 20 ml once in a day early morning empty stomach.
In group B,Nisha Amalaki Churnawill be administered in a dose of 3 gm twice daily with Madhu (honey) morning and evening one hour before meal.
The design of the study is single centered , open label , randomized comparative and interventional study.
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
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patients who met the criteria given by NCEP ATP III Waist circumference over 40 inches in men or 35 inches in women Blood pressure over 130/85 mm of Hg Fasting triglyceride level over 150mg/dl Fasting high density lipoprotein cholesterol level less than 40mg/dl in men or 50mg/dl in women Fasting blood sugar over 100mg/dl 2 Homeostatic Model Assesment Insulin Resistant HOMA-IR Score less than 2.9 3 Patients having age between 21 to 60 years with irrespective of gender 4 Subjects who are able to take medicine orally 5 Subjects who are willing to sign the informed consent.
排除标准
- •1 Fasting blood sugar more than 140 mg/dl 2 Blood Pressure over more than 140/90 mm of Hg 3 Type I and Type II Diabetes mellitus with major complications such as Heart Disease and Stroke Diabetic Nephropathy,Diabetic Retinopathy,Peripheral Neuropathy 4 Systemic illness such as tuberculosis, carcinoma and patient having the history of Myocardial infarction or unstable angina 5 Patient having major renal or liver disorders 6 Lactating mothers and pregnant females 7 Substance abusers such as alcohol 8 Subjects who are registered in any other research project.
结局指标
主要结局
Reduction in HOMA-IR Score
时间窗: Day 0 and Day 90
次要结局
- Reduction in the levels of(Sr. Triglyceride)
研究者
Dr Prachi Brahma
Chaudhary Brahm Prakash Ayurved Charak Sansthan