Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type I… (NCT06224803) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes
Taiwan56 participantsStarted 2020-08-26
Plain-language summary
At present, diabetic patients mainly use drugs to control blood sugar. However, drugs have side effects and the control effect varies among individuals. Even if diabetic patients can control their blood sugar well, long-term medication will still cause a series of complications, including retinopathy, nephropathy, diabetic foot, heart disease, etc. Vascular disease issues, etc.
This study will focus on the changes in HbA1c and blood sugar in patients with confirmed diabetes after taking "Dibifree®" food supplement.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Age: 20 years old (inclusive) or above, gender is not restricted
✓. Diagnosed with type 2 diabetes
✓. HbA1c \> 6.5%
✓. Coagulation function and platelets are normal
✓. Participants voluntarily join this treatment course and sign the informed consent form
✓. Not taking other supplements containing blood sugar regulating properties for at least one month
Exclusion criteria
✕. Women who are pregnant, lactating or planning to have children
✕. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.
✕. Uncontrolled hypertension (\>180/110 mmHG)
✕. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases
✕. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications.
✕. GOT\>4 times normal value; GPT\>4 times normal value
✕. Creatinine\>4 times the highest normal value
What they're measuring
1
Concentration of HbA1c
Timeframe: HbA1c was measured at baseline (V0) and during follow-up visits at months 3 (V3), 4 (V4), and 7 (V7) after intervention.
2
Body Weight and BMI
Timeframe: Body weight and BMI were measured at baseline (V0) and at the end of the 7-month intervention (V7).
Trial details
NCT IDNCT06224803
SponsorGlobal Preventive Medicine Biotech Co., Ltd.