A Single Centre Pilot Open Label Clinical trial to assess the Safety and Efficacy of Glysikot granule both as a Monotherapy and as Adjuvant Therapy in patients with Type 2 DM - PPV Project

Clinfound Clinical Research Services P Ltd0 个研究点目标入组 50 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 30-60 age, both sex.
•2.Body mass index (BMI) below 40 kg/mÂ².
•1.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 Metformin alone 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.Under 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 >1.4 mg/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, Psycho-Neuro- Endocrinal disorders, etc.)

发起方

Clinfound Clinical Research Services P Ltd