Health Condition 1: null- Diabetes Mellitus : Type 1 and Type 2
Conditions
Interventions
Intervention1: Noni Whole Fruit freeze-dried powder provided as a single-use sachet: Noni 3.3 grams powder given twice daily on empty stomach for 12 weeks
Control Intervention1: Diabetic patients not
Sponsors
Surya Herbal Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Men and women ≥25 years of age Written informed consent from the subject. A diagnosis of diabetes either type 1 or type 2.
Exclusion criteria
Exclusion criteria: 1. Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to Screening. 2. Subjects participating in any other clinical trial or herbal supplement investigation. 3. Subjects on any other herbal therapy / supplement for diabetes 4. Uncontrolled diabetes mellitus (known hemoglobin A1c [HbA1c] 12% within the last 1 month prior to Screening) 5. Subjects living too far from the participating center or unable to return for follow-up visits 6. Subjects who in the opinion of the Investigator are a poor medical or psychiatric risk for therapy with an investigational supplement, are unreliable, or have an incomplete understanding of the study which may affect their ability to take the supplement as prescribed or comply with instructions 7. Known human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), or tuberculosis infection 8. Acute bacterial, fungal or viral infection 9. Women who are pregnant or are planning for pregnancy. 10. Any diabetics who have concomitant chronic renal failure or chronic heart failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine whether 12 weeks of dietary supplementation with Noni along with the standard of care is superior to standard of care alone for improving glucose control among diabetics.Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess if the requirement of glucose-lowering medication would be reduced following the 12 - week supplementation with Noni in diabetic subjects. 2. To determine any side effects that may occur as part of the Noni dietary supplement.Timepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Prem Anand Nagaraja
Outcome results
None listed