Evaluation of the Efficacy of Short-term Noni Herbal Supplement in Subjects with Diabetes mellitus
- Conditions
- Health Condition 1: null- Diabetes Mellitus : Type 1 and Type 2
- Registration Number
- CTRI/2011/04/001697
- Lead Sponsor
- Surya Herbal Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 60
Men and women ≥25 years of age
Written informed consent from the subject.
A diagnosis of diabetes either type 1 or type 2.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method