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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PreCrea | Experimental | 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. |
|
| Placebo 600 mg capsules | Placebo Comparator | Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study dietary supplement (PreCrea 600 mg capsules) | Dietary Supplement | 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function | Measure changes in Liver Function Tests: Aspartate Aminotransferase (AST) from baseline (Day 1) to End of Study (Day 90); Alanine Aminotransferase (ALT) from baseline (Day1) to End of Study (Day 90); Alkanine Phosphatase (ALP) from baseline (Day1) to End of Study (Day 90 | Baseline (Day 1) to End of Study (Day 90) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dia Care- Diabetes Care and Hormone Clinic | Ahmedabad | Gujarat | 380015 | India | ||
| St. Johns College and Hospital |
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|
| Placebo | Dietary Supplement |
|
|
| Bangalore |
| Karnataka |
| 560034 |
| India |
| Totall Diabetes and Hormone Institution | Indore | Madhya Pradesh | 452010 | India |
| Bhatia Hospital | Mumbai | Maharashtra | 411007 | India |
| Inamdar Multispeciality Hospital | Pune | Maharashtra | 411040 | India |
| Diabetes Care Centre | Jaipur | Rajasthan | 302018 | India |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018149 | Glucose Intolerance |
| D006943 | Hyperglycemia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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