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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

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Pre-Diabetes Hyperglycemia Metabolic Syndrome Dietary Supplement: Study dietary supplement (PreCrea 600 mg capsules) Dietary Supplement: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : November 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
Dietary Supplement: Placebo
Other Name: Placebo 600mg capsules




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189005


Locations
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India
Dia Care- Diabetes Care and Hormone Clinic
Ahmedabad, Gujarat, India, 380015
St. Johns College and Hospital
Bangalore, Karnataka, India, 560034
Totall Diabetes and Hormone Institution
Indore, Madhya Pradesh, India, 452010
Bhatia Hospital
Mumbai, Maharashtra, India, 411007
Inamdar Multispeciality Hospital
Pune, Maharashtra, India, 411040
Diabetes Care Centre
Jaipur, Rajasthan, India, 302018
Sponsors and Collaborators
Joe Fenn
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Responsible Party: Joe Fenn, Sponsor-Medical Director, PreEmptive Meds, Pvt. Ltd
ClinicalTrials.gov Identifier: NCT02189005    
Other Study ID Numbers: Precre/Nutra001/PMI13
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: May 18, 2015
Last Verified: May 2015
Keywords provided by Joe Fenn, PreEmptive Meds, Pvt. Ltd:
High blood sugar
High HbA1C
hyperglycemia
Pre-Diabetes
Natural Supplement for Diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Metabolic Syndrome
Hyperglycemia
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Resistance
Hyperinsulinism