A Randomized, multi-center, Double Blind, Interventional, Placebo Controlled Study To Evaluate Efficacy and Safety of ALIMFUS - Airborne Low Intensity Multi frequency Ultrasound, as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type II Diabetic Patients
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- 2. To compare change in HbA1C% (Glycosylated Hemoglobin) value between the groups (Before and after treatment).
研究概览
简要总结
It is a randomized, multi-center, double blind, interventional, placebo controlled study to evaluate efficacy and safety of ALIMFUS - Airborne Low Intensity Multi frequency Ultrasound, as an Add-on therapy to Oral Hypoglycemic Agent (OHA) in Type II Diabetic Patients. The study will be conducted at three sites in India. As per computer generated randomization list, Subjects will be randomized to either of the two groups i.e. OHAs (daily) + Exposure to low frequency airborne ultrasound for 10 minutes (alternate day) for 3 months or OHAs (daily) + Exposure to placebo waves for 10 minutes (alternate day) for 3 months. The primary objectives of the study will be to compare change in QOL (diabetes) over three months of the study treatment between the groups and to compare change in HbA1C% (Glycosylated Hemoglobin) value between the groups (Before and after treatment). The secondary objectives of the study will be to compare monthly changes in fasting and postprandial plasma glucose levels over three months of study treatment between the groups,.monthly assessment of changes in the clinical symptoms of Diabetes Mellitus (Poly urea, Polyphagia, Polydipsia and Fatigue), to compare change in HOMA IR score between the two groups (Before and after treatment), to compare change in fasting serum Insulin level between the groups (Before and after treatment), to compare monthly change in dose and type of OHAs between the groups, to compare monthly changes in weight, BMI, waist circumference, Hip Circumference, waist: Hip ratio Basal Metabolic Rate (BMR), Body fat percentage (Instrumental evaluation), total body water, lean body mass (LBM), Neck circumference, Upper mid arm circumference, calf circumference between the groups, to compare change in Hs-CRP, Interleukin-6, TNF-α, Homocysteine, Vitamin D, Serum Leptin, Serum Adiponectin between the groups (before and after treatment) and to assess tolerability of study treatments by assessing ADRs and assessment of safety laboratory investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects suffering from 2 Diabetes Mellitus on regular diet and mono or poly drug anti-diabetic therapy 2.At screening visit, patient should have their HbA1C in range of 7-10 percent 3.ECG not demonstrating any signs of uncontrolled arrhythmia or acute ischemia.
- •4.Subjects voluntarily signing informed consent form and willing to follow the procedures as per the study protocol.
排除标准
- •Subjects having known hepatic or renal disease
- •Subjects having an active malignancy and tuberculosis
- •Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization.
- •Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy and Diabetic wounds requiring treatment.
- •Subjects having chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Use of any other investigational drug within 1 month prior to randomization
- •Known hypersensitivity to ultra sound.
- •Pregnant and Lactating females.
- •Subjects having skin allergy
- •Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
结局指标
主要结局
2. To compare change in HbA1C% (Glycosylated Hemoglobin) value between the groups (Before and after treatment).
时间窗: Day -7, Day 0, Day 30, Day 60, Day 90
1. To compare change in QOL (diabetes) over three months of the study treatment between the groups
时间窗: Day -7, Day 0, Day 30, Day 60, Day 90
次要结局
- 1. Monthly changes in FBS and PPBS.(2. Monthly changes in the clinical symptoms of DM)