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Clinical Study on the Safety and Efficacy of Danzhi Jiangtang Capsules in Intervening Pre-diabetes

Clinical Study on the Safety and Efficacy of Danzhi Jiangtang Capsules in Intervening Pre-diabetes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001637
Enrollment
Unknown
Registered
2025-09-01
Start date
2025-06-20
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

pre-diabetes

Interventions

experimental group:Danzhi Jiangtang Capsules, for oral administration. 2.4g each time, three times a day, with a treatment course of 2 months.
control group:Danzhi Jiangtang Capsules for oral administration. 1.2g each time three times a day with a treatment course of 2 months.

Sponsors

The First Affiliated Hospital of Anhui University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Subjects who meet the criteria for prediabetes in Western medicine diagnosis standards (6.1 mmol/L = fasting blood glucose < 7.0 mmol/L; 7.8 mmol/L = 2-hour postprandial blood glucose < 11.1 mmol/L; 5.7% = glycosylated hemoglobin < 6.5%; at least 2 of the above 3 indicators must be satisfied). (2) Subjects with prediabetes who meet the criteria for qi-yin deficiency syndrome in traditional Chinese medicine (TCM) diagnosis standards (can be diagnosed with 2 main symptoms: fatigue and lassitude dry mouth and thirst). (3) Aged 20–70 years (inclusive) regardless of gender. (4) Subjects who are informed of the study and voluntarily sign the informed consent form. (5) Those who are willing to comply with the doctor's treatment plan and cooperate with follow-up.

Exclusion criteria

Exclusion criteria: (1) Having had acute cardiovascular and cerebrovascular events or myocardial infarction within 6 months. (2) Those with proliferative retinopathy requiring laser treatment. (3) Those in a state of stress or with secondary hyperglycemia. (4) Unwilling to cooperate (unable to comply with diet and exercise control or fail to take medication as prescribed). (5) Those with mental illness. (6) Pregnant or lactating women women planning to become pregnant or women without contraceptive plans. (7) Those who may be allergic to the study drug. (8) Those with other endocrine diseases or other severe primary diseases.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;two-hour postprandial glucose;

Secondary

MeasureTime frame
hemoglobin A1c;Traditional Chinese Medicine syndrome score;fasting insulin;

Countries

China

Contacts

Public ContactFang Zhaohui

The First Affiliated Hospital of Anhui University of Chinese Medicine

fangzhaohui9097@163.com13965059097

Outcome results

None listed

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