A Prospective, randomized, open-label, comparative study to evaluate the efficacy and safety of standardized 10% β –glucogallin (Saberry), an extract of Emblica officinalis against Metformin 500mg in newly diagnosed patients of type 2 diabetes mellitus associated with dyslipidemia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 3
- 主要终点
- 1. Mean % percentage change in HbA1c from screening to final visit.
研究概览
简要总结
Diabetes Mellitus is a major public health challengeof the twenty-first century. Increasing Levels of Urbanization,Industrialization and economic advancement adversely affect the biological andenvironmental risk factors for Diabetes and other non-communicable diseases.Unhealthy diet, physical inactivity and stress factors cause overweight andinsulin resistance. This study entitled “A Prospective, randomized,open-label, comparative study to evaluate the efficacy and safety ofstandardized 10% β –glucogallin (Saberry), an extract of Emblica officinalisagainst Metformin 500mg in newly diagnosed patients of type 2 diabetes mellitusassociated with dyslipidemiaâ€.
All the parameters of assessment will be based on thesigns and symptoms as mentioned in study criteria. Patients fulfillingthe criteria will be selected and divided in three arms groups and followed bya filling of consent form in language best understood by them - firstintervention arm as one capsule of Saberry once a day, second intervention armas one capsule of Saberry twice a dayand third intervention arm as one tablet of Metformin once a day and dependingon randomization code patients will bereceiving either Saberry or Metformin.
Allthe parameters will be assessed before and after treatment based on thespecially prepared proforma, Appropriate test will be applied to the dataoutcome and discussion and conclusion will be made accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female of 30 to 65 years old inclusive of both.
- •2.Body Mass Index (BMI) range 27to 35 kg/m
- •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.
排除标准
- •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.
- •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.
结局指标
主要结局
1. Mean % percentage change in HbA1c from screening to final visit.
时间窗: 1. Mean % percentage change in HbA1c (Screening and Day90). | 2. Mean change in fasting plasma glucose and post prandial plasma glucose (Screening,Day30,Day60 and Day90).
2. Mean change in fasting plasma glucose and post prandial plasma glucose from screening to final visit.
时间窗: 1. Mean % percentage change in HbA1c (Screening and Day90). | 2. Mean change in fasting plasma glucose and post prandial plasma glucose (Screening,Day30,Day60 and Day90).
次要结局
- 1.Mean change in Lipid Profile from screening to final visit.(2.To compare the mean change in HbA1c, fasting plasma glucose, post - prandial plasma glucose and lipid profile with 1gm/day & 2gm/day dose of Saberry® tablets.)