Evaluation of efficacy of Polyherbal metabolites in Type II Diabetes Mellitus

Phase 2

Conditions: Health Condition 1: E119- Type 2 diabetes mellitus without complications

Registration Number: CTRI/2021/12/038384

Lead Sponsor: Apex laboratories private limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in HbA1C levels in 12th week. <br/ ><br>Reduction in Fasting and Postprandial Blood glucose levels at 4th,8th & 12th weekTimepoint: Reduction in HbA1C levels after 12 weeks <br/ ><br>Reduction in Fasting and Postprandial Blood glucose levels at 4th week 8th & 12th week

Secondary Outcome Measures