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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
210
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.
Dia Care- Diabetes Care and Hormone Clinic
Ahmedabad, Gujarat, India
St. Johns College and Hospital
Bangalore, Karnataka, India
Totall Diabetes and Hormone Institution
Indore, Madhya Pradesh, India
Bhatia Hospital
Mumbai, Maharashtra, India
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
Time frame: 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)
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
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
Time frame: Day 1 (Baseline) to Day 90 (End of Study)
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Inamdar Multispeciality Hospital
Pune, Maharashtra, India
Diabetes Care Centre
Jaipur, Rajasthan, India