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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097506
Enrollment
Unknown
Registered
2025-02-19
Start date
2023-10-20
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Type 2 diabetes splenasthenic syndrome

Interventions

Treatment group: treated spleen soup and taken orally.200ml, twice a day for 14 days
control group:Metformin tablets, taken orally, 2 tablets each time, twice a day

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. Those with spleen deficiency of traditional Chinese medicine; 3. Blood glucose [7.0 mmol/L <=FPG (venous blood) <=10.0mmol/L; 7.0% <HbA 1 c (HbA 1 c) <=9.0%]; 4. Age 30 ~75 years (including both ends), gender limitation; 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 complicated with acute complications of diabetes mellitus; 3. Combined with severe heartand cerebrovascular diseases and severe primary diseases such as liver, kidney and hematopoietic system; 4. People with known allergies and allergies to the study drug; 5. Pregnant andlactating pregnant women and women with recent family planning; 6. Patients with long-term alcoholism, drug dependence, and mental illness; 7. Those who have participated in or are attending other drug clinicaltrials within one month before the screening period of the study; 8. The investigator is not inappropriate to attend the clinical investigator.

Design outcomes

Primary

MeasureTime frame
fasting blood-glucose ;Blood glucose at 2 hours after the meal;

Secondary

MeasureTime frame
glycosylated hemoglobin;Fasting insulin;Fasting C peptide;And 2-hour postprandial insulin;C peptide;

Countries

China

Contacts

Public ContactZhao Jindong

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

zhaojindong1111@163.com+86 152 5657 1336

Outcome results

None listed

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