An Open-labelled, Single Arm, Interventional Pilot Study to Evaluate the Efficacy and Safety of DyberineTM in Adult Subjects with Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- M R HEALTHCARE PVT LTD
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in HbA1c from screening to end of study (Day 60)
Overview
Brief Summary
This open-labelled, single-arm interventional clinical study aims to evaluate the efficacy and safety of Dyberine powder (200 mg twice daily) in 20 adult subjects with Type 2 Diabetes Mellitus over a 60-day treatment period. The primary objective is to determine the effect of Dyberine on glycemic control, assessed by changes in HbA1c levels. Secondary objectives include evaluating changes in fasting and postprandial blood sugar, body weight, BMI, waist circumference, clinical symptoms, and laboratory safety parameters, as well as monitoring adverse events. Eligible participants are 18 to 65 years old, diagnosed with Type 2 diabetes and having HbA1c more than or equals to 7.0 and BMI 27 to 45. Individuals with Type 1 diabetes, uncontrolled metabolic values, major systemic illnesses, or recent use of alternative therapies or other investigational drugs are excluded. Assessments are conducted across four site visits: Screening, Baseline, Follow-up at Day 30, and End of Study at Day 60. Key evaluations include vital signs, anthropometric measurements, blood glucose monitoring, HbA1c, laboratory tests, and adverse event reporting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex between the age group 18 to 65 years; Patients who are diagnosed with Type 2 Diabetes mellitus; Patients with HbA1c euals to 7 percent or more; Subjects with BMI more than 27 and less than 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
- •Subjects with Type 1 diabetes mellitus, severe hyperglycemia FBS more than 240 or PPBS more than 360, fasting serum cholesterol more than 260 and serum Triglycerides more than 300; 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; History of smoking more than 10 cigarettes per day or alcohol intake more than 30 ml per day; Subjects with Ischemic heart disease with any cardiac event in last 6 months; Participants who have participated in any investigational study in the last 4 weeks; 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 in the last one month; Pregnant or lactating females and women in child bearing age refusing to use of contraceptive methods.
Outcomes
Primary Outcomes
Change in HbA1c from screening to end of study (Day 60)
Time Frame: screening to Day 60
Secondary Outcomes
- Change in fasting blood sugar (FBS); postprandial blood sugar (PPBS); 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 events)
Investigators
Dr Giri Raja KV
Rajalakshmi Hospital and Research Center