ISRCTN83308122
Completed
Not Applicable
Six-month clinical trial to investigate the effect of Hintonia latiflora in the dietetic treatment of mild and moderate type 2 diabetes mellitus
Gehrlicher Pharmazeutische Extrakte GmbH (Germany)0 sites40 target enrollmentSeptember 7, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild and moderate diabetes mellitus of type II (age-related)
- Sponsor
- Gehrlicher Pharmazeutische Extrakte GmbH (Germany)
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Type 2 diabetics
- •2\. Between the ages of 45 and 80
- •3\. Neither oral antidiabetic agents nor insulin were used
- •4\. Prescribed diet had led to stable but not nearly normoglycaemic values
- •As a condition for inclusion in the study, diabetic symptoms must have existed for a period of at least 12 months. The values for fasting blood sugar had to be in the range from 7\-14 mmol/l (normal value: 3\.9\-5\.4 mmol/l).
Exclusion Criteria
- •To be excluded were patients for whom there was a doubt about the reliability with respect to the adherence to the dietetic guidelines (e.g., with regard to alcohol consumption). Other exclusion reasons were severe diabetic symptoms, progressive life\-threatening diseases, hepatic dysfunction or renal insufficiency (deviations of GOT, ?GT and AP of more than twice the normal value, serum creatinine \> 130 µmol/l), hypoglycaemic crises not noticed in time, retinopathy, pregnancy, malignant tumours and/or drug or alcohol dependence in the medical history.
Outcomes
Primary Outcomes
Not specified
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