CTRI/2017/03/008057进行中（未招募）不适用
A Single Centre Pilot Open Label Clinical Trial to assess the Safety and Efficacy of Diadropsz Arka as a Monotherapy and as an Adjuvant in Patients with Type 2 Diabetes Mellitus
Clinfound Clinical Research Services PvtLtd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study).
研究概览
简要总结
Most of the othertreatment methods for diabetes mellitus regard it as a largely dietary disease.But Ayurveda here differs widely in its outlook. Ayurveda does not regarddiabetes mellitus as a disease that can be treated by mere medicine or by adietary regimen. The Ayurvedic treatment for diabetes mellitus is based on anentire change in the lifestyle of the person.The current study looks at the efficacy of an Ayurveda combination in Diabetes Melittus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Body mass index (BMI) below 40 kg/m².
- •Group A 1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
- •2.Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or 3.Fasting Plasma Glucose (FPG) ≥130 mg/dL Group B.
- •1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
- •2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) ≥7.5% and ≤11% or a Fasting Plasma Glucose (FPG) ≥130 mg/dL.
排除标准
- •1.Type 1 diabetes.
- •2.Current need for Insulin treatment.
- •3.Complication of DM.
- •4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S.
- •creatinine > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •5.Women who are pregnant or lactating 6.Smokers/Alcoholics and/or drug abusers
- •Patient with poorly controlled Hypertension
- •Patients with evidence of malignancy
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis.
结局指标
主要结局
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12 (End of study).
时间窗: Baseline and Week 12 (End of study).
次要结局
- Change from Baseline in Fasting Plasma Glucose (FPG)(Baseline Day 10 Day 20 Day 30)
- Change from Baseline in 2-hr Post-Meal Glucose (PMG)(Baseline Day 10 Day 20 Day 30)
- Changes from Baseline in BMI(Baseline Day 10 Day 20 Day 30)
- Symptomatic changes assessed using Ayurvedic symptom questionnaire(Baseline Day 10 Day 20 Day 30)
研究者
研究点 (1)
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