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

Global Preventive Medicine Biotech

Status: Completed

Conditions: Type II Diabetes

Treatments: Dietary Supplement: Indigestible dextrin; Dietary Supplement: Compound plant extracts

Study type: Interventional

Funder types: Industry

Identifiers

NCT06224803

DF202006001

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups, including a placebo group

Dibifree

Experimental group

Description:

Take Dibifree 3 times a day, 10 capsules each time, 5 to 10 minutes before meals

Treatment:

Dietary Supplement: Compound plant extracts

Control

Placebo Comparator group

Description:

Take Placebo 3 times a day, 10 capsules each time, 5 to 10 minutes before meals

Treatment:

Dietary Supplement: Indigestible dextrin