A Prospective study Randomized Comparative clinical study to evaluate the safety and efficacy of synergistic plant metabolite Combination tablets in Type II Diabetes mellitus patients

Apex laboratories private limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年2月21日

试验速览

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•Male or female patients within the age range of 40 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 â?? Newly diagnosed diabetics or diagnosed within past 2 years
•HbA1C between 6.5 - 9.5%

•Type 1 diabetes mellitus
•Patients with severe hyperglycemia (FBS >234 mg% or PPBS > 360 mg%)
•Fasting serum cholesterol >260mg% and serum Triglycerides >300 mg%.
•HbA1C more than 9.5 %.
•AST 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.
•Patients with psychiatric disorder.
•History of smoking (more than 10 cigarettes/day) or alcohol intake
•History or evidence suggestive of complications of diabetes such as • Retinopathy • Nephropathy • Presence of ketone bodies in urine analysis • Ischemic heart disease with any cardiac event in last 6 months • Neuropathy
•BMI >35 kg/m2 or less than 20 kg/m2

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