Evaluation of efficacy of Polyherbal metabolites in Type II Diabetes Mellitus

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/12/038384

Enrollment

Registered

2021-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
Reduction in HbA1C levels in 12th week. Reduction in Fasting and Postprandial Blood glucose levels at 4th,8th & 12th weekTimepoint: Reduction in HbA1C levels after 12 weeks Reduction in Fasting and Postprandial Blood glucose levels at 4th week 8th & 12th week	—

Secondary

Measure	Time frame
Replacement for MetforminTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactKNNANDA KUMAR

SRM Medical College Hospital andResearch Centre

venkatap@srmist.edu.in9791745806

Outcome results