An open labeled, clinical trial to determine the Efficacy and Safety of Succare in patients with diabetes mellitus (Type 1 and Type 2)

atural Solutions0 个研究点目标入组 30 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Aged 30 to 65 years
•Male and female patients with diabetes mellitus with/without CKD.
•Patients with inadequate glucose control on/not on any anti diabetic drugs
•Body mass index between 20-35 kg/m2
•In case of CKD patients as per PI discretion:
•I. eGFR<=90 ml/min and >= 70 ml/min
•II. Presence of protein and Blood in the Urine Having fasting blood glucose > 126 mg/dL
•Post prandial blood glucose > 200 mg/dL
•Having no serious physical or biochemical abnormalities other than those generally associated with diabetes mellitus (Type 1 and Type 2)
•Patient is willing and able to comply with all trial requirements Ability to understand the Informed Consent and Willing to Sign on informed consent accordance with GCP and local legislation. Patients able to understand and follow the protocol of the trial.
•Participants who are able to visit the medical institutions throughout the study period.

•Patients having diabetes other than Insulin dependent & non insulin dependent diabetes mellitus.
•Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs
•Pregnant or lactating women and patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug. Subjects who are already taking or have taken in the past 2 months any investigational drug
•Lack of suitability for participation in the trial, for any reason, as judged by PI History of HIV/HBS/HCV positive serology

发起方

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