A COMPARATIVE STUDY TO EVALUATE THE EFFEICACY OF NIMBADI GHANA VATI AND PHALATRIKADI GHANA VATI IN THE MANAGEMENT OF MADHUMEHA (TYPE 2 DIABETES MELLITUS)- A RANDOMISED CONTROLLED CLINICAL TRIAL.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Reduction in the level of Glycosylated haemoglobin (HbA1c).
研究概览
简要总结
Diabetes mellitus is a complex disorder of multiple etiology resulting in chronic hyperglycemia resulting from the defect in insulin action, insulin secretion, or both .Diabetes mellitus becomes burden to the global and especially in India because of the high prevalance rate which has risen from 7.1% in 2009 to 8.9% in 2019, currently , 25.2 million adults are estimated to have impaired glucose tolerance, which has estimated to increase to 35.7 million in the year 2045.
Various treatment modalities are available in conventional medical science such as use of oral hypoglycemic agents but, prolonged use of OHA and their side effects and uncertainity of safety profile thus, need to establish the newer treatment choices which cause minimal side effects and plant based medicines have that strength to correct the condition of hyperglycemia .Changing lifestyles, job patterns, and dietary habits increase the risk of type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Either gender in the age group 30-60 yrs with classical signs and symptoms of Madhumeha. 2.Patients fulfilling the general diagnostic criteria for diabetes mellitus.(as per diabetic protocol by MOA/AIIA). 3.RBS more than or equal to 200 to 450 mg/dl. 4.FBS more than or equal to 126 to 350 mg/dl. 5.PPBS more than or equal to 200 to 450 mg/dl. 6.Glycosylated haemoglobin more than or equal to 6.5% to 15%. 7.Newly/early diagnosed cases to be included as per following criteria:.
- •patients accidentally diagnosed in routine check-up or when appeared with other complaints in the hospital.
- •early diagnosed diabetic patients (< 3yrs of diabetes) and not taking any pharmacological drugs.
- •patients who used to take conventional medicines and stopped taking them for 3 months & were willing to take Ayurvedic Medicines.
排除标准
- •1.Patients having insulin dependent DM(type1) and receiving OHA.
- •2.Age <30yrs and>60yrs, pregnant women and lactating mothers.
- •3.Excessive blood sugar:FBS>350mg/dl and PPBS>450mg/dl.
- •4.Emergency conditions in cases of DM, chronic complications and patients with other diseases such as chronic liver diseases, thyroid disorders, hypertension, CKD, heart diseases etc.
- •5.Patients who were not fit for yoga.
结局指标
主要结局
Reduction in the level of Glycosylated haemoglobin (HbA1c).
时间窗: (DAY-0)(DAY-7)(DAY-14)(DAY-30)(DAY-45)(DAY-60)(DAY-75)(DAY-90)
次要结局
- 1.Improvement in the signs and symptoms of Madhumeha after 90days.(2.Reduction in the level of FBS & PPBS at 30th,60th and 90th day of the study .)