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

Not Applicable

Completed

• Conditions: Type II Diabetes
• Interventions: Dietary Supplement: Compound plant extracts; Dietary Supplement: Indigestible dextrin

• Registration Number: NCT06224803
• Lead Sponsor: Global Preventive Medicine Biotech Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-26
• Primary Completion: 2021-07-21
• Study Completion: 2022-01-18
• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-17
• Last Update Submitted: 2024-01-17
• Study First Posted: 2024-01-25
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dibifree	Compound plant extracts	Take Dibifree 3 times a day, 10 capsules each time, 5 to 10 minutes before meals
Control	Indigestible dextrin	Take Placebo 3 times a day, 10 capsules each time, 5 to 10 minutes before meals

Primary Outcome Measures

Name	Time	Method
Concentration of HbA1c	per 30 days for 7 months	Concentration of HbA1c is assessed every 30 day for 7 months

Secondary Outcome Measures

Name	Time	Method
Concentration of Blood Sugar	everyday for 7 months	AC \& PC blood sugar is measured and recorded by the subjects everyday for 7 months

Trial Locations

Locations (1)

Global Preventive Medicine Biotech Co., Ltd.; 🇨🇳 New Taipei, Taiwan