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Efficacy of fermented tangerine peel dark tea for the glycemic control in type 2 diabetes mellitus patients: a multicenter, randomized, control, open-label, superiority clinical trial

Efficacy of fermented tangerine peel dark tea for the glycemic control in type 2 diabetes mellitus patients: a multicenter, randomized, control, open-label, superiority clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063402
Enrollment
Unknown
Registered
2022-09-06
Start date
2023-02-13
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus

Interventions

Intervention group:drink fermented tangerine peel dark tea + receive diet and exercise counseling
control group:receive diet and exercise counseling

Sponsors

Guangzhou Red Cross Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with diabetes according to diagnostic criteria in Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition); 2. Not abke to keep the blood sugar levels within the target range using dietary treatment with metformin: received metformin >= 1500 mg/day for at least 8 weeks, had hemoglobin A1c (HbA1c) of 7% to 9%and fasting blood glucose < 13.9 mmol/L; 3. Aged 18-70 years (included 18 and 70 years); 4. Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI) 2.5 times the upper limit of normal value serum total bilirubin, serum creatinine, serum triglycerides >= 1.5 times the normal value, or Electrocardiogram (ECG), carotid B-ultrasound, cardiac B-ultrasound examination showed cardiovascular dysfunction; 3. Urinary microalbumin to creatinine ratio > 30 mg/g; 4. Severe diabetic ketoacidosis or severe infection; 5. Severe gastrointestinal disease; 6. Pregnancy or lactation; 7. History of tumor; 8. Severe peripheral neuropathy; 9. The investigator did not consider it appropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
change of glycosylated hemoglobin from baseline;

Secondary

MeasureTime frame
sugar tolerance;insulin;attainment rate of glycosylated hemoglobin;

Countries

China

Contacts

Public ContactRongshao Tan

Guangzhou Red Cross Hospital

tanrongshao@126.com+86 18928900312

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026