A polyherbal supplement (DiabelynTM) for control of blood sugar in treatment naive early type II diabetes mellitus subjectsÃ¢â?¬?. - Diabelyn Study

Herbalyn Lifesciences Inc0 个研究点目标入组 100 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•a.Male or female patients of 25 to 60 years, both inclusive
•b.Have newly diagnosed treatment naÃ?Â¯ve type II diabetes for greater than or equal to 3 months based on the disease diagnostic criteria.
•c.Subjects are treatment-naÃ?Â¯ve, not optimally controlled with diet and exercise alone, not received treatment with any anti-hyperglycemic medications.
•d.Fasting Plasma Glucose more than or equal to 120 mg/dL to less than or equal to 150 mg/dl in the subject.
•e.Have a body mass index (BMI) less than or equal to 35.00 kg/m2.
•f.Subject who will follow all study related procedures and willing to take rescue medication for use as per requirement for the duration of the study.

•a.Pregnant or lactating or planning to become pregnant and women with reproductive potential unwilling to follow standard contraception methods.
•b.Subjects having type 1 diabetes mellitus, gestational diabetes, secondary diabetes.
•c.Any history suggestive of microvascular or macrovascular disease
•d.Impaired renal function; eGFR less than 60 ml/min/1.73 m2
•e.Known history of any chronic illness taking regular pharmacological agents
•f.Subjects diagnosed with uncontrolled hypertension.
•g.Subjects who have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 60 days prior to screening.
•h.History of asthma, hypertension, thrombotic events, stroke, congestive heart failure, impaired cognitive function, and impaired hepatic function.
•i.Known hypersensitivity to any of the study products.
•j.History of use of any nutraceutical products in the last four weeks prior to screening.

发起方

Herbalyn Lifesciences Inc