A clinical study to evaluate the efficacy and safety of NATBERB as a add on therapy for Type 2 diabetes Mellitus

An Open-labelled, Single Arm, Interventional Clinical Study to Evaluate the Efficacy and Safety of NATBERB (100% Natural Berberine) as an adjuvant therapy in Type 2 Diabetes mellitus

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051904

Enrollment

Registered

2023-04-24

Start date

Unknown

Completion date

Unknown

Last updated

2024-08-19

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: 1. Patients of either sex between the age group 18 to 55 years(both inclusive). 2. Patients who are diagnosed as suffering from Type 2 Diabetes mellitus. 3. Patients with HbA1c = 7.0%. 4. Subjects with Body Mass Index (BMI) >27 kg/m2 and

Exclusion criteria

Exclusion criteria: 1.Type 1 diabetes mellitus 2.Patients with severe hyperglycemia (FBS >240 mg% or PPBS >360 mg%) 3.Patients with fasting serum cholesterol >260mg% and serum Triglycerides >300 mg%. 4.Patients with HbA1c more than 10.5 %. 5.Patients with ASAT and ALT levels greater than 2.5 times the upper normal limits 6.Severe renal, hepatic or respiratory disorder.

Design outcomes

Primary

Measure	Time frame
To evaluate Changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting blood sugar and post prandial blood sugar. Timepoint: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60	—

Secondary

Measure	Time frame
To observe the quality of life by evaluating the reduction in Body mass index (BMI) and changes in lipid profile, TSH, Serum creatinine and bilirubin.Timepoint: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60.	—

Countries

India

Contacts

Public ContactMeena Dalal

Trial Guna Pvt Ltd

dr.r.n.sharma@gmail.com8867125414

Outcome results