Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of PreCrea® on subjects with higher than normal blood sugar levels.

Detailed Description
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A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, study to evaluate the efficacy and safety of PreCrea®, a twice-daily dietary supplement in people with higher than normal blood sugar levels.

Official Title
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A Prospective, Double Blind, Placebo-Controlled, Randomized, Multicentric, Study to Evaluate the Efficacy and Safety of PreCrea®, a Twice-daily Dietary Supplement in People With Higher Than Normal Blood Sugar Levels.

Conditions
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Metabolic Syndrome, Diabetes Mellitus, Pre-Diabetes, Hyperglycemia

Intervention / Treatment
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* Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years to ≤ 65 years Newly diagnosed Male or Female participants with higher than normal blood sugar levels (FPG >100 mg/dL) on of Pre-Diabetes and Diabetes Mellitus during screening and not on any treatment Ability to understand and willingness to sign and date a written Informed Consent Document at the screening visit before any protocol- specific procedures are performed and willing to adhere to the protocol and entire trial procedures Exclusion Criteria: Subjects with Type 1 Diabetes Mellitus Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months. Cardiac status New York Heart Association class III-IV Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic Impaired renal function as shown by but not limited to serum creatinine ≥ 1.5 mg/dl for males and ≥ 1.4 mg/dl for female Clinically significant peripheral edema Clinical evidence of active liver disease or serum alenine aminotransferase (ALT) or aspartate amino transferase (AST) 2.5 times the upper limit of the normal range (2.5 X ULN) Participants on steroid Pregnancy or lactating women Known hypersensitivity to any of the study drugs Any malignancy within the last 5 years, with exception of adequately treated basal or squamous cell carcinoma of the skin or adequately treated carcinoma insitu. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study. Subject unlikely to comply with protocol e.g. uncooperative attitude, inability to return for follow up visits and unlikelihood completing of the study. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PreCrea<br>Study dietary supplement (Precrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification program. | Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)<br>* Study dietary supplement (PreCrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification.<br>* Other names: PreCrea, Natural Sugar Lowerig Supplement, Predisease;|
| Placebo Comparator: Placebo 600 mg capsules<br>Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program. | Dietary Supplement: Placebo<br> <br> * Other names: Placebo 600mg capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels | Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days | Day 1(Baseline) to Day 90 (End of Study) | 
| Safety of Dietary Supplement PreCrea 600 mg twice-daily | Measure changes in Renal Function Tests: Blood Urea Nitrogen (BUN) from baseline (Day 1) to end of study (Day 90); Serum Creatinine from baseline (Day 1) to end of study (Day 90) | Day 1 (Baseline) to Day 90 (End of Study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG) | Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days | Day 1 (Baseline) to Day 90 (End of Study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High blood sugar, High HbA1C, hyperglycemia, Pre-Diabetes, Natural Supplement for Diabetes