RecruitingPhase 2ACTRN12615000233527

An investigative study on the safety and efficacy of French Maritime Pine Bark Extract, Papain and Aloe Vera in pre-diabetic participants

A Phase IIa Double-Blind Placebo Controlled Clinical Trial Investigating the Efficacy and Safety of Arborvitae Health and Wellbeing Supplement on the Blood Glucose Levels in Pre-Diabetic Participants.


Sponsor

Arborvitae Health and Wellbeing Pty Ltd

Enrollment

116 participants

Start Date

Mar 26, 2015

Study Type

Interventional

Conditions

Summary

The objective of study is to evaluate the safety and efficacy of the investigational product (Pinus Pinaster, Papain, Aloe vera) in pre-diabetic participants following oral adminstration of 50 mL twice daily.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether a natural supplement containing French Maritime Pine Bark Extract, Papain, and Aloe Vera is safe and effective for people who have pre-diabetes (slightly elevated blood sugar). Participants take 50 mL of the supplement twice a day to see whether it can help bring blood sugar levels closer to normal. You may be eligible if: - You are 18 years of age or older - Your fasting blood glucose is between 6.1 and 6.9 mmol/L (indicating pre-diabetes) You may NOT be eligible if: - You have been diagnosed with type 2 diabetes - You have other major illnesses considered clinically significant - You are taking anti-obesity medications or dietary supplements - You have a problem with alcohol use - You have recently started a diet or exercise program to manage your blood sugar Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

50 mL of active components or placebo is given by oral solution twice daily. Compliance will be checked by the count of bottles returned and participant's diary. Participants over the age of 18 who de

50 mL of active components or placebo is given by oral solution twice daily. Compliance will be checked by the count of bottles returned and participant's diary. Participants over the age of 18 who demonstrate IFG 6.1-6.9 mmol/L will be recruited for this study. Participants will attend a total of 5 visits. The total duration of the whole study is 12 weeks. Active components composition: Aloe vera 1.75 mg/mL Papain 2.4 mg/mL Pinus pinaster 2.6 mg/mL Sodium chloride 3 mg/mL


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ACTRN12615000233527


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