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The clinical effect evaluation of taking JinHua Instant Dark Tea in Solid Form among type 2 diabetes mellitus patients

The clinical effect evaluation of taking JinHua Instant Dark Tea in Solid Form among type 2 diabetes mellitus patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080339
Enrollment
Unknown
Registered
2024-01-26
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-28

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

Treatment group:Conventional drug therapy and additionally take JinHua Instant Dark Tea in Solid Form in the morning, noon and evening after meals, each time with one packet (1 g / packet)
Control group:Conventional drug therapy, not taking JinHua Instant Dark Tea in Solid Form

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1)18 = age = 65; (2)Patients with self-reported type 2 diabetes diagnosed by an endocrinologist or Patients meeting the diagnostic criteria according to Guideline for the prevention and treatment of type 2 diabetes mellitus in China (2020 edition):?Pre-diabetic population which have fasting plasma glucose level between 6.1 mmol/l and 7 mmol/l (100~125mg/dl) , or two-hour postprandial glucose level between 7.8 mmol/l and 11 mmol/l (140~199mg/dl), or HbA1c between 5.7% and 6.4%; or?Patients diagnosed with diabetes which have fasting plasma glucose level=7mmol/L(126mg/dl), or two-hour postprandial glucose level =11.1mmol/L (200mg/dl), or HbA1c =6.5%; (3)Patients with Stable condition after dietary control or maintenance dose of oral hypoglycemic therapy only (4)Patients with normal functioning of vital organs such as the heart, brain and kidneys and no diabetic complications (5)Patients who are allowed to follow up for at least 1 year (6)Patients with comparatively regular dietary pattern and exercise regimen (7)Patients agreeing to participate in this study and signing the informed consent form

Exclusion criteria

Exclusion criteria: (1)Patients who are taking hormonal drugs; (2)Patients with acute complications of diabetes mellitus(infection,diabetic ketoacidosis); (3)Patents with other endocrine diseases(pituitary,adrenal or thyroid diseases, etc); (4)Patients with severe gastrointestinal disorders(functional dyspepsia,irritable bowel syndrome); (5)Patients with impaired renal function; (6)Maternity or lactation (7)Persistent drinker(alcohol consumption>15g for female and >25g for male) (8)Any other medical or psychological condition, in the opinion of the investigator, that may cause an inability to cooperate in the fulfillment of this study.

Design outcomes

Primary

MeasureTime frame
HbA1c;

Secondary

MeasureTime frame
fasting plasma glucose level;two-hour postprandial glucose level;Weight;BMI;Total cholesterol;triglyceride;High density lipoprotein cholesterol;low-density lipoprotein cholesterol;Diabetes remission rate;

Countries

China

Contacts

Public ContactYu Jiajie

West China Hospital of Sichuan University

yujiajie@wchscu.cn+86 182 0012 0874

Outcome results

None listed

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