Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes

Type II Diabetes Clinical Trial

Official title:

Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06224803
• Other study ID #: DF202006001
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes

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