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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06224803
Other study ID # DF202006001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2020
Est. completion date January 18, 2022

Study information

Verified date January 2024
Source Global Preventive Medicine Biotech Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date January 18, 2022
Est. primary completion date July 21, 2021
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Age: 20 years old (inclusive) or above, gender is not restricted 2. Diagnosed with type 2 diabetes 3. HbA1c > 6.5% 4. Coagulation function and platelets are normal 5. Participants voluntarily join this treatment course and sign the informed consent form 6. Not taking other supplements containing blood sugar regulating properties for at least one month Exclusion Criteria: 1. Women who are pregnant, lactating or planning to have children 2. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc. 3. Uncontrolled hypertension (>180/110 mmHG) 4. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases 5. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications. 6. GOT>4 times normal value; GPT>4 times normal value 7. Creatinine>4 times the highest normal value 8. Those who are determined by the project administrator to be unfit to participate in this clinical study

Study Design


Intervention

Dietary Supplement:
Compound plant extracts
Total supplement including bitter melon (Momordica charantia) fruit extract, celery (Apium graveolens) seed extract, baker's yeast (Saccharomyces cerevisiae) cell wall extract, acerola (Malpighia emarginata) fruit extract, grape (Vitis vinifera) seed extract, green tea leaf extract, and hydrolyzed soy protein powder.
Indigestible dextrin
Indigestible dextrin as placebo intervention

Locations

Country Name City State
Taiwan Global Preventive Medicine Biotech Co., Ltd. New Taipei

Sponsors (1)

Lead Sponsor Collaborator
Global Preventive Medicine Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of HbA1c Concentration of HbA1c is assessed every 30 day for 7 months per 30 days for 7 months
Secondary Concentration of Blood Sugar AC & PC blood sugar is measured and recorded by the subjects everyday for 7 months everyday for 7 months
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