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Sspleen soup combined with metformin for type 2 diabetes Randomized controlled clinical study of spleen deficiency syndrome

Anhui Province Fang Zhaohui famous traditional Chinese medicine studio

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2023000035
Enrollment
Unknown
Registered
2023-08-24
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Type 2 diabetes

Interventions

treatment group :Ginseng technique adjusts spleen soup

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Type 2 diabetes patients who meet the Western medicine diagnostic criteria for diabetes; (2) Patients with spleen deficiency of traditional Chinese medicine; (3) Poor control: blood glucose [7.0 mmol/L FPG (venous blood) 10.0mmol/L;7.0% <HbA 1 c (HbA 1 c) 9.0%]; (4) Age is 30 ~60 years old (including both ends), gender is not limited; (5) The subject was informed and voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with type 1 diabetes, gestational diabetes, type 2 diabetes and other special types of diabetes that need insulin therapy; (2) Patients with acute complications of diabetes mellitus; (3) Severe cardiac and cerebrovascular diseasesand serious primary diseases, such as liver, kidney and hematopoietic system; (4) People with known allergies and allergic constitution to the study drug; (5) Pregnant and lactating women and women with recent familyplanning; (6) Long-term alcoholism, drug dependence, and patients with mental illness; (7) Those who have participated in or are participating in other drug clinical trials within one month before the screening period of the study; (8) Theinvestigator is not inappropriate to attend the clinical investigator.

Design outcomes

Primary

MeasureTime frame
Fasting blood glucose and 2-h postprandial blood glucose;

Secondary

MeasureTime frame
Intestinal flora in stool;Bile acid in stool;Short chain fatty acid;fasting insulin (FINS),;TCM Syndrome Integral Scale;Glycosylated serum protein;(A - DQOL);

Countries

China

Contacts

Public ContactZhao Jindong

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

zhaojindong1111@163.com15256571336

Outcome results

None listed

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