Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: 500 mg Berbabsorb™ extract Tablets: Twice a day, after meal for 90 days.
Intervention2: 250 mg Berbabsorb™ extract Tablets: Twice a day, after meal for 90 days.
Control Intervention1: 5
Sponsors
Konark Herbals and Healthcare Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female participants between age 30-65 years (both inclusive). 2.Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination)Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy. In the event of poor glycemic control, or safety concerns, the investigator may initiate standard-of-care treatment for type 2 diabetes mellitus. 3.Glycated haemoglobin (HbA1c) more than 6.5% and less than 8% (both inclusive). 4.Fasting Plasma Glucose (FPG) more than 130 mg/dL and less than 250 mg/dL (both inclusive);5.Participants willing to comply with the study procedure and sign written informed consent. 6.Participants with a BMI of more than 28 and less than 35 kg/m2. 7.Participants with or without deranged lipid profile.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes; 2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including Insulin treatment; 3.Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT more than 3 times of the upper normal limit) or renal dysfunction (defined as S. creatinine more than 1.4 mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease; 4.Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (e.g., hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (more than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment; 5.Smokers/Alcoholics and/or drug abusers; 6.Participants with evidence or history of malignancy; 7.Involvement in any other clinical trial requiring drug therapy; 8.Pregnant or lactating women or women of fertile age not using effective contraception; 9.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in Glycemic profile by assessing a) Fasting, and post-meal plasma glucose levels from screening to the end of the study and b) HbA1c levels at screening and end of the study. 2.Changes in Insulin resistance by assessing Fasting insulin, HOMA-IR score at screening and end of the study.Timepoint: At Screening, Day 30, Day 60, Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in lipid metabolism by assessing cholesterol, LDL, HDL, Triglycerides etc., at screening & end of the study. 2.Changes in Metabolic Syndrome Severity Z Score (MetZ score) at screening & end of the study. 3.Changes in anthropometric parameters like body weight, BMI, & waist circumference from screening to end of the study. 4.Changes in diabetes-related quality of life score assessed by DQOL questionnaire score to assess quality of life at screening & end of the study.Timepoint: At Screening, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
Public ContactMr Vedant Gupta
Mprex Healthcare Pvt Ltd
Outcome results
None listed