Health Condition 1: R739- Hyperglycemia, unspecified
Conditions
Interventions
Intervention1: Group 1: Berberis aristata extract and Phyllanthus emblica extract 500 mg capsule (NextBeri™).: Twice a day after breakfast and after dinner for 180 days.
Intervention2: Group 2: Berber
Sponsors
Pharmanza Herbal Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and females aged 20 to 60 years (both inclusive); 2. 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); 3. Participants with Hemoglobin A1c (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%; 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); 5. IDRS (Indian Diabetics Risk score) less than or equal to 60; 6. Participants providing voluntary, written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Participants with type 1 or type 2 diabetes mellitus gestational diabetes or secondary diabetes; 2. Participants with any other co-morbidity; 3. Participants treatment of a glucose-lowering or weight loss agent within 90 days before screening; 4. Participants with elevated liver enzymes AST and or ALT greater than 3 times of the upper normal limit; 5. Participants with abnormal renal function as measured by eGFR less than 45ml per min per 1.73 meter square; 6. Participants who had bariatric surgery; 7. Pregnant or lactating women; 8. Smokers alcoholics and or drug abusers; 9. Participants with a known history or ongoing malignancy; 10. Participants with the treatment of immunosuppressive medications in the past three months; 11. Participants suffering from major systemic illness necessitating medical care; 12. Any other reason that can affect the participation of the subject in the study as per investigators discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in Glycemic profile by assessing 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.Timepoint: 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
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Siddharth J Modi
Pharmanza Herbal Pvt. Ltd.
Outcome results
None listed