A randomized, double-blinded, double dummy, parallel, comparative study to evaluate the efficacy and safety of ß-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia - NI

Sam Sabinsa Group Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

暂无简介。

•1.Participants should be willing to give a written informed consent.
•2.Participants should be willing to comply with the requirements of the trial/ study.
•3.Male and female participants aged between 25-65 years.
•4.Females with childbearing potential who agree to use a barrier method of contraception throughout the study period.
•5.Participants, newly diagnosed with Type 2 Diabetes (T2DM) and is drug-naive with FBS between126 to 210 mg/dL
•PPBS between 200 to 300 mg/dL
•HbA1c between 6.5 to 8.9 %.
•6.Lipid parameters:
•Total Cholesterol between 200 to 300 mg/dL,
•Triglyceride between 160 to 300 mg/dL,
•LDL between120 to 200 mg/dL.
•7.Ability to swallow and retain oral medications as per the protocol.

•1. History of Smoking and Alcohol intake (within 3 months before screening)
•2. Type-1 Diabetes
•3. Presence of chronic gastrointestinal diseases, severe immune deficiencies, lactose intolerance.
•4. Use of any lipid lowering therapies in the past 3 months.
•5. Patient on antihypertensive medications.
•6. Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases.
•7. Patient who have participated in any clinical trial within the past 3 months.
•8. Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
•9. Any planned surgery during study.

发起方

Sam Sabinsa Group Limited