A Randomized, placebo-controlled study to assess the efficacy & safety of the combination of Berberis aristata and Phyllanthus emblica extract supplementation in prediabetic subjects.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Pharmanza Herbal Pvt. Ltd
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- 1. Changes in Glycemic profile by assessing
Overview
Brief Summary
Standardized extracts of Berberis aristataand Phyllanthus emblica contain constituents that can regulate blood sugar levels and aid in the management of prediabetes. The purpose of this study is to evaluate the safety and effectiveness of Berberis aristata and Phyllanthus emblicaextract capsules in prediabetic individuals. By combining the current research and clinical trials on the pharmacological benefits of micronutrients, it is possible to address the critical medical concern of the expanding prediabetic population by enhancing glycemic control, halting the progression of the disease, and potentially reversing the condition. This study employs a randomized, controlled clinical methodology to evaluate the efficacy and safety of nutritional supplementation in individuals at risk of developing diabetes. There will be daily telephonic follow-up of subjects for the absence of major lifestyle changes that would impact the study outcomes. The clinical validation of the investigational product compared to placebo will offer diabetologists and caregivers evidence and guidance for the therapeutic usage of standardized nutrients and phytoconstituents in the management of prediabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Male and females aged 20 to 60 years (both inclusive);
- •Participants with BMI greater than or equal to 25.00 and less than or equal to 34.9 kg/meter square at screening (Overweight to obese class I);
- •Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%;
- •Participants with Fasting Plasma Glucose (FPG) between 100-125 mg/dl (both inclusive), 2 hours glucose value between 140-199 mg/dl (both inclusive);
- •IDRS (Indian Diabetics Risk score) less than or equal to 60;
- •Participants providing voluntary, written informed consent to participate in the study.
Exclusion Criteria
- •Participants with type 1 or type 2 diabetes mellitus gestational diabetes or secondary diabetes;
- •Participants with any other co-morbidity;
- •Participants treatment of a glucose-lowering or weight loss agent within 90 days before screening;
- •Participants with elevated liver enzymes AST and or ALT greater than 3 times of the upper normal limit;
- •Participants with abnormal renal function as measured by eGFR less than 45ml per min per 1.73 meter square;
- •Participants who had bariatric surgery;
- •Pregnant or lactating women;
- •Participants with a known history or ongoing malignancy;
- •Participants with the treatment of immunosuppressive medications in the past three months;
- •Participants suffering from major systemic illness necessitating medical care;
Outcomes
Primary Outcomes
1. Changes in Glycemic profile by assessing
Time Frame: 1. a)At screening and Day 180, b)At screening and Day 180, c) On Day 45, Day 90 and Day 135. 2. a)At screening and Day 180, b)At screening and Day 180. 3. At screening, Day 90 and Day 180. 4. a)At screening and Day 180, b) At screening and Day 180. 5. a)At screening and Day 180, b) At screening and Day 180, c) At screening and Day 180, d)At screening and Day 180, e) At screening and Day 180. 6. At screening and Day 180. 7. At screening, Day 90 and Day 180. 8. At screening, Day 90 and Day 180.
a) Oral Glucose Tolerance Test (OGTT), b) HbA1c, c) fasting and post-meal plasma glucose levels. 2. Changes in Insulin resistance by assessing a) Fasting insulin, b) HOMA-IR score. 3. Change in Fat metabolism by assessing Blood Lipid Profile. 4. Change in Oxidative stress markers by assessing a) Serum MDA levels, b) Serum SOD levels. 5. Change in Inflammatory markers by assessing a) TNF-alpha levels, b) CRP levels, c) IL-6 levels, d) SIRT 1 e) SIRT 6. 6. Change in Metabolism by assessing Metabolic Syndrome Severity Z Score. 7. Change in Anthropometric parameters by assessing Body weight, BMI and waist circumference. 8. Change in Quality of life by assessing HRQOL-15D questionnaire score.
Time Frame: 1. a)At screening and Day 180, b)At screening and Day 180, c) On Day 45, Day 90 and Day 135. 2. a)At screening and Day 180, b)At screening and Day 180. 3. At screening, Day 90 and Day 180. 4. a)At screening and Day 180, b) At screening and Day 180. 5. a)At screening and Day 180, b) At screening and Day 180, c) At screening and Day 180, d)At screening and Day 180, e) At screening and Day 180. 6. At screening and Day 180. 7. At screening, Day 90 and Day 180. 8. At screening, Day 90 and Day 180.
Secondary Outcomes
- The safety of the intervention will be assessed by evaluating 1. Adverse events profile from baseline to end of the study 2. Tolerability and compliance of the investigational product from baseline to end of the study. 3. Changes in biochemical parameters like liver function test (LFT), renal function test (RFT), GFR and hematological profile at screening and end of the study 4. Changes in vital signs like blood pressure, heart rate etc throughout the study.(1. At baseline, Day 45, Day 90, Day 135, Day 180. 2. At baseline, Day 45, Day 90, Day 135, Day 180. 3. At Screening and Day 180. 4. At Screening, Baseline, Day 45, Day 90, Day 135, Day 180.)
Investigators
Dr Mohan Magdum
MJM Hospital