Clinical validation of safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes- an open label single arm prospective study.

Mr Ghanshyam Goti0 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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•Patients between 18-60 (both inclusive) age, both sex.
•Patients receiving Oral Hypoglycemic Agents and/or insulin as on-going treatment for diabetes
•Haemoglobin A1C (HbA1c) >6.5% and <12% (both inclusive)
•Subjects having a body mass index (BMI) of 20 to 35 kg/m2.
•Fasting Plasma Glucose (FPG) >130 mg/dL and < 250 mg/dL (both inclusive)

•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.
•Women who are pregnant or lactating
•Smokers/Alcoholics and/or drug abusers
•Patients with evidence of malignancy
•Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.)
•Involvement in any other study requiring drug therapy
•Renal dysfunction as evidenced by raised serum creatinine from renal function test
•Uncontrolled hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
•Unwillingness to undergo therapy
•Known hypersensitivity to any of the ingredients of study tablets
•Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol

发起方

Mr Ghanshyam Goti