CTRI/2019/05/019027已完成2 期
Randomised double blind, placebo controlled clinical trial to assess the Safety and Efficacy of NRL/LP/201901 capsules as Adjuvant Therapy in patients with Type 2 Diabetes Mellitus. - NI
etsurf Communications Pvt Ltd0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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 between 30-60 (both inclusive) age, both sex.
- •Patients receiving Oral Hypoglycemic Agents as ongoing treatment for Type 2 DM .
- •Hemoglobin A1c (HbA1c) >6.5% and <10% (both inclusive)
- •Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)
排除标准
- •Type 1 diabetes.
- •Under Insulin treatment
- •Patients with concurrent serious Hepatic Dysfunction (defined asAST and/or ALT >3 times of the upper normal limit) or RenalDysfunction (defined as S. creatinine >1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •Women who are pregnant or lactating
- •Smokers/Alcoholics and/or drug abusers
- •Patients with evidence of malignancy
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
- •Involvement in any other study requiring drug therapy
- •Renal dysfunction as evidenced by raised serum creatinine from renal function test
- •History of serious arrhythmia or atrioventricular block on baseline electrocardiogram
- •Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
- •Unwillingness to undergo therapy
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