CTRI/2008/091/000054尚未招募2 期
A Proof of Concept prospective, double blind, placebo controlled, randomized, multi-¬centric study to evaluate the safety and activity of PHP-Diabetes in patients with Type 2 Diabetes mellitus receiving oral anti-diabetic agents
Council of Scientific Industrial Research New Delhi0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients satisfying all the following criteria are included in the study:
- •1. Patients of either sex between the age group 18 to 60 years (both inclusive).
- •2. Patients with type 2 diabetes mellitus (with duration of diabetes at least 2 years) on sulfonylurea (SU) (half of the maximum prescribed dose) and/or Metformin (1500mg/day) for at least one month prior to enrolling the patient in the study
- •3. Patients with fasting blood glucose more than 126mg % and /or with post-prandial blood glucose (after a standard meal) more than 162mg. %.
- •4. Patients with HbA1c between 7.0-9.5 %.
- •5. Patients ready to abide by trial procedures and to give informed consent.
排除标准
- •A.1. Patients suffering from any of the following conditions will be excluded from the study:
- •a.Type 1 diabetes mellitus
- •b.Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%)
- •c.Patients with fasting serum cholesterol >260mg% and serum Triglycerides>300 mg%.
- •d.Patients with HbA1c >9.5 %.
- •e.Patients with ASAT and ALT levels greater than 2.5 times than upper normal limits
- •f.Severe renal, hepatic or respiratory disorder.
- •g.Patients with psychiatric disorder.
- •h.Patients with haematological disorders
- •i.History of smoking (more than 10 cigarettes/day) or alcohol abuse
- •j.Complications of diabetes such as
- •Proliferative type retinopathy
- •Nephropathy with laboratory values greater than 1.5 times the upper normal limits
- •Presence of ketone bodies in urine analysis
- •Ischemic heart disease with any cardiac event in last 6 months
- •Fasting serum cholesterol >260mg. % and serum Triglycerides >300 mg%.
- •2.Patients with BMI >35 kg/m2
- •3.Patients who are likely to undergo surgery during the study period.
- •4.Patients who have participated in any investigational study in the last 4 weeks.
- •5.Patients having known hypersensitivity to the study drugs.
- •6.Patients with any severe infection
- •7.Patients with a history of intake of ANY Ayurvedic/herbal/homeopathic/dietary supplements (including Vitamin E) or any alternative therapies in the last one month
- •8.Patient should not be receiving on any other anti-diabetic medications except Metformin and those belonging to the Sulfonylurea group.
- •B. Pregnant or lactating females and women in child bearing age refusing to use contraceptives.
研究者
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