A randomized, double-blinded, double dummy, parallel, comparative study to evaluate the efficacy and safety of β-amyrin Palmitate with Activated Curcumin Complex combination versus Metformin in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- To assess the efficacy of beta –amyrin Palmitate with Activated Curcumin Complex (AC3) combination on blood glucose level.
研究概览
简要总结
The study involves 96 subjects randomized in two arms and will receive 120 days of treatment and telephonic follow-up after 7 days following the last visit. Participants will be randomized to receive either Beta-Amyrin Palmitate with activated curcumin complex (Arm-1) or Metformin-500mg (Arm-2) group. Specific biomarkers like fasting blood sugar, serum insulin, HbA1c will be measured and analysed during the study period. The final statical analysis and study report will be complied at the end of the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •History of Smoking and Alcohol intake (within 3 months before screening)
- •Type-1 Diabetes
- •Presence of chronic gastrointestinal diseases, severe immune deficiencies, lactose intolerance.
- •Use of any lipid lowering therapies in the past 3 months.
- •Patient on antihypertensive medications.
- •Patient with history of clinically significant thyroid disorder, gastrointestinal, cardiovascular, haematological, hepatic, renal, respiratory, active malignancies or genitourinary abnormalities or diseases.
- •Patient who have participated in any clinical trial within the past 3 months.
- •Pregnant and lactating women and those not willing to follow a reliable and effective contraceptive measure during the study.
- •Any planned surgery during study.
结局指标
主要结局
To assess the efficacy of beta –amyrin Palmitate with Activated Curcumin Complex (AC3) combination on blood glucose level.
时间窗: 1. Screening to 120 days | 2. Screening to 120 days
1. Mean percentage change in HbA1c from screening to final visit.
时间窗: 1. Screening to 120 days | 2. Screening to 120 days
2. Mean change in fasting blood glucose & postprandial blood sugar from screening to final visit.
时间窗: 1. Screening to 120 days | 2. Screening to 120 days
次要结局
- 1. To compare Mean change in lipid profile –TG, LDL, VLDL, HDL, & TC.(2. To compare the mean change in HbA1c, fasting blood glucose and post-prandial blood sugar between active and reference arm.)