A Single Centre Pilot Open Label Clinical trial to assess the Safety and Efficacy of Pramehoushadhi Tablets as a Monotherapy and an adjuant in patients with Type 2 Diabetes Melitus

Clinfound Clinical Research Services Pvt Ltd0 个研究点目标入组 0 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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•1.Patients between 30-65 age, both sex.
•2.Body mass index (BMI) below 40 kg/mÂ².
•1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
•2.Hemoglobin A1c (HbA1c) >=7.5% and <=11%
•3.Fasting Plasma Glucose (FPG) >=130 mg/dL
•1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
•2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL

•1.Type 1 diabetes.
•2.Current need for Insulin treatment.
•3.Complication of DM.
•4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
•5.Women who are pregnant or lactating
•6.Smokers/Alcoholics and/or drug abusers
•7.Patient with poorly controlled Hypertension
•8.Patients with evidence of malignancy
•9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis

发起方

Clinfound Clinical Research Services Pvt Ltd