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

NCT ID: NCT02189005

Last Updated: 2015-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-11-30

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.

Conditions

Diabetes Mellitus; Pre-Diabetes; Hyperglycemia; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Study dietary supplement (PreCrea 600 mg capsules)

Intervention Type: 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.

Placebo 600 mg capsules

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PreCrea, Natural Sugar Lowerig Supplement, Predisease; Placebo 600mg capsules

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Joe Fenn

INDUSTRY

Sponsor Role: lead

Responsible Party

Joe Fenn

Sponsor-Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Inamdar Multispeciality Hospital

Pune, Maharashtra, India

Diabetes Care Centre

Jaipur, Rajasthan, India

Countries

India

Other Identifiers

Precre/Nutra001/PMI13

Identifier Type: -

Identifier Source: org_study_id