Single arm, open label, prospective clinical trial to assess the safety and efficacy of Gplife Advanced Diabetic Support Tablet as adjuvant therapy in patients with diabetes

Mr Ghanshyam Goti0 sites30 target enrollmentStarted: TBDLast updated: November 24, 2021

Trial Snapshot

No summary available.

•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 <14.5 % (both inclusive)
•Subjects having a body mass index (BMI) of 20 to 35 kg/m2.
•Fasting Plasma Glucose (FPG) >120 mg/dL and < 450 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

Sponsor

Mr Ghanshyam Goti