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: Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

• Registration Number: CTRI/2023/04/051904
• Lead Sponsor: Herbal Creations (A Unit of Kumaon Exports Pvt. Ltd.)

Brief Summary

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.Treatment group: Subjects with Type 2 Diabetes Mellitus will be administered with Berberine.Total of 30 subjects.Visit 1/Day 0- ICF and Screening procedures such as; Hematological Investigations, Serological Investigations, Urinalysis and UPT ï‚· Visit 2/Day-1-Enrollmentï‚· Visit 3/Day 15-, FBS, PPBS ï‚· Visit 4/Day 30-FBS, PPBS ï‚· Visit 5/Day 45- FBS PPBS ï‚· Visit 6/Day 60 EOS In-person visit- repeat of all screening procedures such as; Hematological Investigations, Serological Investigations, Urinalysis and UPT

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-25
• Study Completion: 2024-01-30
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients of either sex between the age group 18 to 55 years(both inclusive).
• Patients who are diagnosed as suffering from Type 2 Diabetes mellitus.
• Patients with HbA1c ≥ 7.0%.
• 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	Day 0, Day 1, Day 15, Day 30, Day 45 and Day 60
blood sugar and post prandial blood sugar.	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	changes in lipid profile, TSH, Serum creatinine and bilirubin.

Trial Locations

Locations (1)

TrialGuna Private Limited; 🇮🇳 Bangalore, KARNATAKA, India

TrialGuna Private Limited

🇮🇳Bangalore, KARNATAKA, India

Dr Rajendra Narayan Sharma

Principal investigator

8867125414

dr.r.n.sharma@gmail.com