CTRI/2010/091/000389招募中3 期
A STUDY TO EVALUATE THE EFFECT OF EDIBLE OIL (RBS8020) IN PATIENTS OF TYPE II DIABETES MELLITUS & HYPERTENSIO
Adani Wilmar Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or Female > or = 18 yrs of age.
- •DM diagnosed at least 3 months prior to screening.
- •HT diagnosed at least 1 month prior to screening
- •The subject should have HbA1c > or = 7.0 % and < or = 11.5 % on screening
- •The subject should have msDBP > or = 85 mm Hg and <110 mm Hg on screening.
- •The subject should be on a stable dose of OHAs and anti hypertensive for 1 month prior to screening.
- •If patient is on lipid lowering agents, therapy should be stable for 1 month prior to screening
- •Body Mass Index > or = 20 kg/m2 and < or = 45 kg/m2.
- •Subject should be capable of understanding and complying with protocol
- •requirements.
- •Subject or the subject`s legally acceptable representative signs a written, informed consent form prior to initiation of any study procedure.
- •No major illness or debility that in the investigator`s opinion prohibits the subject from completing the study.
排除标准
- •History / Evidence of allergy or hypersensitivity to any edible oils used for preparing food.
- •Subjects receiving Insulin for treatment of DM.
- •History of a psychiatric disorder that will affect the subject`s ability to participate in the study.
- •History of alcohol or substance abuse within the 2 years prior to screening.
- •History of treatment with any weight loss drugs or oral or systemically injected steroids within 3 months prior to screening.
- •Receipt of any investigational drug within the 30 days prior to screening.
- •Prior treatment in an investigational study of any edible oil used for preparing food.
- •Subject is a study site employee, or is an immediate family member of a study site employee who is involved in the conduct of this study.
- •Systolic blood pressure > 180 mm Hg and / or diastolic pressure >110 mm Hg.
- •Lab values for exclusion:
- •Serum Triglycerides >500 mg/dl LDL Cholesterol- >200 mg/dl FBS- <110 mg/dl and >240 mg/dl
- •History of any haemoglobinopathy that may affect determination of HbA1c.
- •Patient has had any of the following within the past 12 months.
- •a) Acute coronary syndrome (e.g. : MI or unstable angina)
- •b) Coronary artery intervention (CABG or PTCA)
- •c) Stroke or transient ischemic neurological disorder.
- •Patient has congestive cardiac failure or a history of congestive heart failure.
- •Subject with any significant ECG abnormalities
- •Subject with any life threatening illness or any history of cancer or malignancy.
- •History of any serological abnormality or infection with HIV.
- •Subject on use of antioxidants or omega 3 supplements.
研究者
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