A Prospective, randomized, open-label, comparative study to evaluate the efficacy and safety of standardized 10% Î² â??glucogallin (Saberry), an extract of Emblica officinalis against Metformin 500mg in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia.

Sami Labs Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male and female of 30 to 65 years old inclusive of both.
•2.Body Mass Index (BMI) range 27to 35 kg/m2.
•3.Females with child bearing potential who agree to use barrier method of contraception throughout the study period.
•4.Newly Diagnosed of Type 2 Diabetes (T2DM) and is drug naive with FBS >130 mg/dL; PPBS >210mg/dL; HbA1c >6.5%.
•5.Lipid parameters: Total Cholesterol >200mg/dL,
•Triglyceride >160 mg/dL, LDL >140 mg/dL.
•6.Patients willing to follow suggested diet and a physical activity by the study doctor for a minimum of 30 min for 5 days in a week.
•7.Patients must be willing to come for regular follow-up visits.
•8.Willing to sign informed consent.

•1.Pregnant and lactating female and having the intention to be pregnant within next three months.
•2.History of Smoking & Alcohol intake (within 3 months before screening).
•3.Type 1 diabetes.
•4.With chronic gastrointestinal diseases, severe immune deficiency, lactose intolerance.
•5.Use of any lipid-lowering therapies in the past 3 months.
•6.Patient with TG > 300 mg/dL, LDL > 200 mg/dL, Total cholesterol > 300 mg/dL FBS > 150 mg/dL and PPBS > 300 mg/dL.
•7.Patients with HbA1C > 9.0 % (9.1% excluded)
•8.Patient on antihypertensive medication.
•9.Patient with history of clinically significant thyroid disorder (hypo or hyper), gastrointestinal, cardiovascular, haematological, hepatic (SGOT or SGPT levels > 3 Upper Limit of Normal), renal (serum creatinine >= 1.3 mg/dl), respiratory, active malignancy or genitourinary abnormalities or diseases.
•10.A history of significant multiple and/or severe allergies or anaphylactic reactions.
•11.Patient with known history of hypersensitivity to the investigational product.
•12.Patient has participated in any clinical trial within last 3 months.
•13.Any other condition which the Principal Investigator thinks may jeopardize the study.

发起方

Sami Labs Limited