Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Berberista powder: Berberista powder 500 mg twice a day for 60 days
Control Intervention1: NA: NA
Sponsors
M R HEALTHCARE PVT LTD
Eligibility
Inclusion criteria
Inclusion criteria: Patients of either sex between the age group 18 to 65 years; Patients who are diagnosed with high blood glucose; Subjects with Body Mass Index between 27 to 45; Women of childbearing potential must be willing to use double-barrier contraception for the entire study; Patients ready to abide by trial procedures and to give informed consent
Exclusion criteria
Exclusion criteria: Subjects with Type 1 diabetes mellitus, severe hyperglycemia, fasting serum cholesterol and serum Triglycerides; Subjects with BMI more than 45 and HbA1c more than 10.5; Subjects with severe renal, hepatic or respiratory disorder; Subjects with psychiatric, and hematological disorders; Subjects with Ischemic heart disease with any cardiac event in last 6 months; Participants who have participated in any investigational study; Patients having known hypersensitivity to the study drugs; Patients with a history of intake of any Ayurveda, herbal, homeopathic, dietary supplements or any alternative therapies; Pregnant or lactating females and women in child bearing age refusing to use of contraceptive methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting and postprandial blood glucose levels from screening to end of study (Day 60)Timepoint: Change in fasting and postprandial blood glucose levels from screening to end of study (Day 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight; BMI; waist circumference; Complete Blood Count (CBC); Liver Function Test (SGOT); Renal Function Test (Creatinine); Total Cholesterol and Triglycerides; clinical symptom scores; Incidence and severity of adverse eventsTimepoint: Screening and Day 60 | — |
Countries
India
Contacts
Public ContactMr Manik Chaudhuri
BIORADIAN LIFESCIENCE
Outcome results
None listed