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Clinical observation and mechanism study of stem cell-derived Dendrobium officinale in the treatment of pre-G3b DKD

Clinical observation and mechanism study of stem cell-derived Dendrobium officinale in the treatment of pre-G3b DKD

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074844
Enrollment
Unknown
Registered
2023-08-17
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Diabetic kidney disease

Interventions

Treatment group:Basic treatment + stem cell Dendrobium officinale buds 1g / day, swallowed after soaking in water.
Control group:Basic treatment

Sponsors

Suzhou Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Conform to the diagnostic criteria of DKD ; 2.TCM syndrome differentiation : Qi and Yin deficiency with blood stasis syndrome ; 3.Age 20-75 years old, regardless of gender ; 4.Estimated glomerular filtration rate ( eGFR ) = 30ml / min / 1.73m2 ; 5.Blood pressure is stable below 160 / 90mmHg ; 6.Glycosylated hemoglobin = 9 % ; 7. Informed consent.

Exclusion criteria

Exclusion criteria: 1.Primary glomerular diseases, secondary glomerular diseases other than DKD or other systemic diseases have been clinically diagnosed. 2.Diabetes ketoacidosis, hyperglycemic hyperosmolar syndrome ( HHS ), infection, severe diabetic foot gangrene occurred within one month. 3.Urinary protein quantification greater than 6g / 24hr. 4.Renovascular hypertension. 5.Patients with malignant hypertension, myocardial infarction, cerebrovascular accident and other critical and severe medical history within six months, combined with congestive heart failure grade I-IV. 6.Cancer, pregnancy or lactation and allergy to related drugs in the treatment plan are not suitable for receiving this treatment plan. 7.Tip may be diabetes mellitus complicated with other kidney diseases : no retinopathy ; gFR decreased rapidly ; a sharp increase in proteinuria or nephrotic syndrome ; the activity of urinary sediment showed an increase in tangible components ; combined with other systemic diseases ( such as autoimmune diseases ) symptoms or signs ; gFR decreased by more than 30 % within 2-3 months after initial treatment with angiotensin converting enzyme inhibitor ( ACEI ) or angiotensin receptor blocker ( ARB ). Abnormal renal function, but no obvious proteinuria ; nephrotic syndrome lasts for a long time ( more than 1 year ), but renal function is normal. 8.suspected or had a history of alcohol and drug abuse. 9.According to the judgment of the researchers, other lesions that reduce the possibility of enrollment or complicate the enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up. 10. Allergic constitutions, such as those with a history of allergies to two or more drugs or foods ; or known to be allergic to the ingredients of this drug. 11. Patients who are participating in clinical trials of other drugs. 12. Mental retardation or psychosis. 13.Combination of other serious diseases may affect the efficacy and safety evaluation. 14.Researchers believe that it is not suitable to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Urinalysis;Urinary albumin;Urinary albumin creatinine ratio;Serum creatinine;Blood serum urea;Cystatin c;eGFR;

Countries

China

Contacts

Public ContactFei Huang

Suzhou Traditional Chinese Medicine Hospital

szhuangfei@126.com+86 130 9260 5344

Outcome results

None listed

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