Clinical study of Gplife Advanced Diabetic Support in patients with diabetes
- Conditions
- Health Condition 1: E139- Other specified diabetes mellituswithout complications
- Registration Number
- CTRI/2019/07/020434
- Lead Sponsor
- Mr Ghanshyam Goti
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method