CTRI/2021/12/038559尚未招募3 期
An open labelled multi-centric clinical trial of safety and efficacy of Feijoa freeze dried powder (FFDP) capsules in treated uncontrolled type 2 diabetic patients
Viridis BioPharma Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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.Type 2 DM patients (with duration of diabetes > 6 months) and treated with oral hypoglycemic medicines. HbA1c between 7 %to 9% .
- •2.Patients in the age group between 19 to 65 years, of either sex.
- •3.Willing to give informed consent.
排除标准
- •1.Type 1 DM patients.
- •2.Type 2 diabetic patients on insulin
- •3.Pregnant women with diabetes
- •4.Lactating mothers with diabetes
- •5.Patient with uncontrolled diabetes, FBG >250mg% or PPBS >400mg% and/or HbA1c > 9.0.
- •6.Patient with uncontrolled dyslipidemia (fasting S. cholesterol >260mg% and S. triglycerides > 300mg% on screening visit)
- •7.Patient with presence of any severe diabetic complication and/or major systemic disease.
- •8.S. Creatinine >1.5%.
- •9.ASAT and ALT >2.5times the upper normal limits.
- •10.Patients with recent stroke or unstable angina or coronary artery diseases in previous 6 months before inclusion.
- •11.Presence of ketone bodies in urine analysis.
- •12.Haemoglobin level below 10 gm%.
- •13.History of substance abuse or alcoholism, within the previous one year.
- •14.Patient with seropositive status.
- •15.Patients who are on corticosteroids or oral contraceptives.
- •16.Participation in clinical trials evaluating investigational pharmaceuticals or biologics within 3 months or devices within 30 days of admission to the study.
- •17.Persons who have suffered from HIV/COVID, patients with Hepatitis C as per information given by patients
研究者
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