CTRI/2022/05/042422尚未招募不适用
A Prospective Randomized Comparative Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- -To evaluate the efficacy of Cresvin Beta capsules in Type II Diabetes Mellitus Patients by means of measuring patient FBS, PPBS and HBA1C values.
研究概览
简要总结
The Patients will be given Cresvin Beta capsules orallyat a dose of 2 tablets twice daily 20minutes before food for a period of 3 months. The Patients will be evaluated atthe beginning of the study, at 4weeks, at 8 weeks and at 12 weeks. Ateach visit the patients will beevaluate for efficacy and any adverse effects, vital examination and laboratory investigation. The efficacy parameters areincidence of Polyuria, Polydipsia, Polyphagiaand peripheral tingling sensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients within the age range of 18 to 60 years (both years inclusive) diagnosed with T2DM for at least 3 months.
- •Willingness to provide written informed consent to participate in the study.
- •Patients understanding the nature and purpose of the study and who are willing to comply with study procedures.
- •Fasting plasma glucose greater than or equal to 126 mg/dL -Random plasma glucose greater than 200 mg/dL in a person with symptoms of diabetes.
- •Duration of diabetes – Newly diagnosed diabetics or diagnosed within past 5 years -HbA1C between 7-9.5%.
排除标准
- •Type 1 diabetes mellitus -Patients with severe hyperglycemia (FBS greater than 234 mg per dl or PPBS greater than 360 mg per dl -HbA1C is more than 9.5 per cent.
- •ASAT and ALT levels greater than 2.5 times the upper normal limits Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological or respiratory disorders, in view of the investigator.
- •ï‚§Patients with psychiatric disorder.
- •ï‚§History of smoking (more than 10 cigarettes/day) or alcohol intake > 20gm/day.
结局指标
主要结局
-To evaluate the efficacy of Cresvin Beta capsules in Type II Diabetes Mellitus Patients by means of measuring patient FBS, PPBS and HBA1C values.
时间窗: 06 months
-To assess adverse drug reactions during the study period.
时间窗: 06 months
次要结局
- -To evaluate the adverse drug reaction during the study period..(06 months)
研究者
研究点 (1)
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