A clinical study to evaluate the efficacy and safety of NATBERB as a add on therapy for Type 2 diabetes Mellitus
Phase 4
Completed
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2023/04/051904
- Lead Sponsor
- Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
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 <45 kg/m2.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate Changes in the diabetic panel, i.e., glycosylated hemoglobin (HbA1C), fasting <br/ ><br>blood sugar and post prandial blood sugar. <br/ ><br>Timepoint: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60
- Secondary Outcome Measures
Name Time Method To observe the quality of life by evaluating the reduction in Body mass index (BMI) and <br/ ><br>changes in lipid profile, TSH, Serum creatinine and bilirubin.Timepoint: Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60.