CTRI/2021/12/038384
Not yet recruiting
Phase 2
A Prospective study Randomized Comparative clinical study to evaluate the safety and efficacy of synergistic plant metabolite Combination tablets in Type II Diabetes mellitus patients
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Sponsor
- Apex laboratories private limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patients within the age range of 40 to 60 years (both years inclusive) diagnosed with T2DM for at least 3 months.
- •Willingness to provide written informed consent to participate in the study.
- •Patients understanding the nature and purpose of the study and who are willing to comply with study procedures.
- •Fasting plasma glucose greater than or equal to 126 mg/dL
- •Random plasma glucose greater than 200 mg/dL in a person with symptoms of diabetes.
- •Duration of diabetes â?? Newly diagnosed diabetics or diagnosed within past 2 years
- •HbA1C between 6\.5 \- 9\.5%
Exclusion Criteria
- •Type 1 diabetes mellitus
- •Patients with severe hyperglycemia (FBS \>234 mg% or PPBS \> 360 mg%)
- •Fasting serum cholesterol \>260mg% and serum Triglycerides \>300 mg%.
- •HbA1C more than 9\.5 %.
- •AST and ALT levels greater than 2\.5 times the upper normal limits
- •Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological or respiratory disorders, in view of the investigator.
- •Patients with psychiatric disorder.
- •History of smoking (more than 10 cigarettes/day) or alcohol intake
- •History or evidence suggestive of complications of diabetes such as • Retinopathy • Nephropathy • Presence of ketone bodies in urine analysis • Ischemic heart disease with any cardiac event in last 6 months • Neuropathy
- •BMI \>35 kg/m2 or less than 20 kg/m2
Outcomes
Primary Outcomes
Not specified
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