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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189005
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : May 18, 2015
Sponsor:
Information provided by (Responsible Party):
Joe Fenn, PreEmptive Meds, Pvt. Ltd

Tracking Information
First Submitted Date  ICMJE July 11, 2014
First Posted Date  ICMJE July 14, 2014
Last Update Posted Date May 18, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels [ Time Frame: Day 1(Baseline) to Day 90 (End of Study) ]
    Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days
  • Safety of Dietary Supplement PreCrea 600 mg twice-daily [ Time Frame: Day 1 (Baseline) to Day 90 (End of Study) ]
    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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
  • Efficacy of Dietary Supplement PreCrea 500 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels [ Time Frame: Day 1(Baseline) to Day 90 (End of Study) ]
    Change in HbA1c % from baseline (Day 1) to end of supplementation/treatment after 90 days
  • Safety of Dietary Supplement PreCrea 500 mg twice-daily [ Time Frame: Day 1 (Baseline) to Day 90 (End of Study) ]
    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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG) [ Time Frame: Day 1 (Baseline) to Day 90 (End of Study) ]
Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2014)
Efficacy of Dietary Supplement PreCrea 500 mg twice-daily in lowering Fasting Plasma Glucose (FPG) [ Time Frame: Day 1 (Baseline) to Day 90 (End of Study) ]
Change in FPG % from baseline (Day1) to end of supplementation/treatment after 90 days
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2015)
Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function [ Time Frame: Baseline (Day 1) to End of Study (Day 90) ]
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
Original Other Pre-specified Outcome Measures
 (submitted: July 11, 2014)
Safety of Dietary Supplement PreCrea 500 mg twice-daily with Liver Function [ Time Frame: Baseline (Day 1) to End of Study (Day 90) ]
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
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Efficacy of PreCrea® on Subjects With Higher Than Normal Blood Sugar Levels
Official Title  ICMJE 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.
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Pre-Diabetes
  • Hyperglycemia
  • Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)
    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.
    Other Name: PreCrea, Natural Sugar Lowerig Supplement, Predisease
  • Dietary Supplement: Placebo
    Other Name: Placebo 600mg capsules
Study Arms  ICMJE
  • Experimental: PreCrea
    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.
    Intervention: Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules)
  • Placebo Comparator: Placebo 600 mg capsules
    Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2015)
210
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2014)
250
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years to ≤ 65 years
  2. 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
  3. 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:

  1. Subjects with Type 1 Diabetes Mellitus
  2. Participants on insulin therapy and other oral anti-diabetic agents or having uncontrolled diabetes.
  3. Stroke, myocardial infarction, coronary artery bypass graft (CABG) percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
  4. Cardiac status New York Heart Association class III-IV
  5. Uncontrolled blood pressure > 150 mmhg systolic and > 100 mmhg diastolic
  6. 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
  7. Clinically significant peripheral edema
  8. 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)
  9. Participants on steroid
  10. Pregnancy or lactating women
  11. Known hypersensitivity to any of the study drugs
  12. 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.
  13. Current addiction or current alcohol abuse or history of substance or alcohol abuse within the last 2 years
  14. 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
  15. 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.
  16. Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189005
Other Study ID Numbers  ICMJE Precre/Nutra001/PMI13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joe Fenn, PreEmptive Meds, Pvt. Ltd
Study Sponsor  ICMJE Joe Fenn
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PreEmptive Meds, Pvt. Ltd
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP