CTRI/2022/04/041781已完成4 期
An Open label, Single arm, clinical Study to evaluate efficacy of Kapiva Dia Free Juice as an adjuvant therapy for Type 2 Diabetic Patients and Improving QO
Kapiva Adret Retail Pvt 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
- 4 期
- 状态
- 已完成
- 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
- •1.Subjects aged > 18 years of age who agree to participate in the study willing and able to answer the questionnaire and give their written informed consent.
- •2. Participant with initial HBA1c value 6.5% and above
- •3. Subjects with a physician certified report on their sugar profile of 3 months
- •prior to enrolment for trial.
- •4. Patients with a diagnosis of T2DM for >1 year prior to signing up for clinical
- •5. Patients who are under the treatment of oral antidiabetic drugs
- •6. Patients who have not changed their medication in the last three months prior
- •to signing up for the study. (However, dosage modifications are allowed)
- •7. Subjects with Body Mass Index (BMI) >27 kg/m2 and <45 kg/m2
- •8. Women of childbearing potential must be willing to use double-barrier contraception for the entire study
排除标准
- •1.Pregnant and lactating women
- •2. Patients who are on insulin therapy.
- •3. Patients with a history of chronic illness type 1 diabetes and /or history of
- •ketoacidosis
- •4. Patients with Insulin use and/or hyperosmolar hyperglycaemic state
- •5. Patients with secondary diabetes (including disease of the exocrine pancreas,
- •endocrinopathies)
- •6. Any condition of the patient which may have an impact on the objective and
- •outcome of the trial example: patients currently undergoing major/ minor surgical procedures
研究者
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