CTRI/2019/11/022083已完成Unknown
An Open labeled, Non Randomized, Clinical study to Evaluate the Glucose Lowering effect of KAL-10 Meal in patients with type 2 diabetes Mellitus
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Evaluate changes in level of HbA1c after 12
研究概览
简要总结
Kerala Ayurveda Limited innovative product KAL-10 meal is a holistic Ayurveda principle based food to help in type 2 diabetes patients lower blood glucose to healthy levels.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group of 18 to 60 years, both inclusive.
- •Patients suffering from Type II Diabetes Mellitus for more than one year, and stabilized on mono / poly oral hypoglycemic drug underanti-diabetic therapy.
- •Patients having HbA1c value below 8% at screening.
- •Patients of female gender or non-pregnant, non-lactating females.
- •A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
- •Patients who willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •Type-I & Type-II Diabetic patients who are on Insulin.
- •Known cases of severe/chronic hepatic or renal disease.
- •Known patient of any active malignancy.
- •Patients giving history of significant cardiovascular event
- •Patients having history of known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
- •Patients having history of known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •Known patients of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •Patients using any other investigational drug within 1 month prior to recruitment
- •Patients currently participating in any other clinical study
- •Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria.
结局指标
主要结局
1. Evaluate changes in level of HbA1c after 12
时间窗: Base line and Week 12
weeks intake of KAL-10 meal
时间窗: Base line and Week 12
次要结局
- 1. Evaluate the effect of KAL-10 meal by(observing changes on FBG and PPG and lipid)
研究者
研究点 (1)
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