Back to results

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

Primary Purpose

Diabetes Mellitus, Pre-Diabetes, Hyperglycemia

Status

Completed

Phase

Phase 3

Locations

India

Study Type

Interventional

Intervention

Study dietary supplement (PreCrea 600 mg capsules)

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring High blood sugar, High HbA1C, hyperglycemia, Pre-Diabetes, Natural Supplement for Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dia Care- Diabetes Care and Hormone Clinic
St. Johns College and Hospital
Totall Diabetes and Hormone Institution
Bhatia Hospital
Inamdar Multispeciality Hospital
Diabetes Care Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PreCrea

Placebo 600 mg capsules

Arm Description

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 was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02189005

First Posted

July 11, 2014

Last Updated

May 14, 2015

Sponsor

Joe Fenn

1. Study Identification

Unique Protocol Identification Number

NCT02189005

Brief Title

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

Acronym

Precrea

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 Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Joe Fenn

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Pre-Diabetes, Hyperglycemia, Metabolic Syndrome

Keywords

High blood sugar, High HbA1C, hyperglycemia, Pre-Diabetes, Natural Supplement for Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

210 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PreCrea

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo 600 mg capsules

Arm Type

Placebo Comparator

Arm Description

Placebo was given to patients twice daily 30 mins before food for 90 days along with lifestyle modification program.

Intervention Type

Dietary Supplement

Intervention Name(s)

Study dietary supplement (PreCrea 600 mg capsules)

Other Intervention Name(s)

PreCrea, Natural Sugar Lowerig Supplement, Predisease

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo 600mg capsules

Primary Outcome Measure Information:

Title

Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Hemoglobin A1c (Hb A1c) levels

Description

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)

Title

Safety of Dietary Supplement PreCrea 600 mg twice-daily

Description

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)

Secondary Outcome Measure Information:

Title

Efficacy of Dietary Supplement PreCrea 600 mg twice-daily in lowering Fasting Plasma Glucose (FPG)

Description

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)

Other Pre-specified Outcome Measures:

Title

Safety of Dietary Supplement PreCrea 600 mg twice-daily with Liver Function

Description

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

Time Frame

Baseline (Day 1) to End of Study (Day 90)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Dia Care- Diabetes Care and Hormone Clinic

City

Ahmedabad

State/Province

Gujarat

ZIP/Postal Code

380015

Country

India

Facility Name

St. Johns College and Hospital

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

560034

Country

India

Facility Name

Totall Diabetes and Hormone Institution

City

Indore

State/Province

Madhya Pradesh

ZIP/Postal Code

452010

Country

India

Facility Name

Bhatia Hospital

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

411007

Country

India

Facility Name

Inamdar Multispeciality Hospital

City

Pune

State/Province

Maharashtra

ZIP/Postal Code

411040

Country

India

Facility Name

Diabetes Care Centre

City

Jaipur

State/Province

Rajasthan

ZIP/Postal Code

302018

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs