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Clinical Trials/CTRI/2019/07/020434
CTRI/2019/07/020434
Not yet recruiting
Phase 2

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 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Mr Ghanshyam Goti
Status
Not yet recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Mr Ghanshyam Goti

Eligibility Criteria

Inclusion Criteria

  • •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)

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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