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Dan Zhi Jiang Tang Capsule in treating type 2 diabetes mellitus with deficiency of Qi and Yin and stasis syndrome

Dan Zhi Jiang Tang Capsule in treating type 2 diabetes mellitus with deficiency of Qi and Yin and stasis syndrome

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100054404
Enrollment
Unknown
Registered
2021-12-17
Start date
2021-12-17
Completion date
Unknown
Last updated
2022-11-20

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

Conditions

Type 2 diabetes mellitus with deficiency of Qi and Yin and stasis syndrome

Interventions

Control group:Diet control + exercise therapy + metformin
Experimental group:Diet control + exercise therapy + metformin + Danzhi Jiangtang Capsules

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years (including both ends), no gender limitation; 2. Patients with type 2 diabetes who meet the diagnostic criteria of Western medicine for diabetes; 3. Those who meet the syndrome of qi and yin deficiency with blood stasis; 4. Those who only received metformin hydrochloride tablets, and 0.5g / time, 3 times / day, not less than 2 weeks; 5. Poor control: blood sugar [6.5mmol/L <= FPG (venous blood) <= 10.0mmol/L; 7.0%<HbA1c (glycated hemoglobin) <= 9.0%]; 6. The subjects were informed and signed the informed consent voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with type 2 diabetes who need insulin treatment; 2. Patients with acute complications of diabetes; 3. Combined with severe heart and cerebrovascular diseases and serious primary diseases such as liver, kidney and hematopoietic system; 4. Those who are allergic to the known ingredients of the research drug and have allergic constitution; 5. Pregnant, lactating women and those who have a childbearing plan in the near future; 6. Long-term alcoholism, drug dependence, mental illness; 7. Patients who have been treated with traditional Chinese medicine or proprietary Chinese medicine for oral hypoglycemic purpose within 1 month before screening; 8. Those who have participated in or are participating in other drug clinical trials within one month before the screening period of this study; 9. The researcher believes that it is not suitable to participate in this clinical researcher.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose;Fasting insulin;Glycosylated serum protein;Diabetes quality of life scale;Bile acids in serum and stool;

Secondary

MeasureTime frame
2h postprandial blood glucose;Glycosylated hemoglobin;

Countries

China

Contacts

Public ContactZhao Jindong

The First Affiliated Hospital of Anhui University of Chinese medicine

zjdahhzyy@126.com+86 13905693329

Outcome results

None listed

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