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The study on the efficacy and mechanism of "Yishen Huoxue Fang" (Kidney-benefiting and Blood-activating Prescription) for the intervention of high-risk populations for the occurrence of diabetic kidney disease through Shenshu acupoint plaster application.

The study on the efficacy and mechanism of "Yishen Huoxue Fang" (Kidney-benefiting and Blood-activating Prescription) for the intervention of high-risk populations for the occurrence of diabetic kidney disease through Shenshu acupoint plaster application.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001373
Enrollment
Unknown
Registered
2025-07-09
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

diabetic kidney disease

Interventions

Control Group :Placebo acupoint application at the Shenshu acupoints
Treatment Group??:"Yishen Huoxue Formula" acupoint application at the Shenshu acupoints

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age: 18 - 80 years old no gender limitation. (2) Meet the above diagnostic criteria for T2DM. (3) Meet the high-risk population identification criteria for DKD occurrence with a score =80 where the score is calculated as: 1+exp(-3.306+0.698×Gastrointestinal Real-Heat Syndrome+0.781×Spleen - Kidney Yang Deficiency Syndrome+1.024×UA+0.911×Duration of Disease+0.042×Age) exp(-3.306+0.698×Gastrointestinal Real-Heat Syndrome+0.781×Spleen - Kidney Yang Deficiency Syndrome+1.024×UA+0.911×Duration of Disease+0.042×Age) ?(4) Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1) Exclude patients with Type 1 diabetes and other non-Type 2 diabetes mellitus (non-T2DM) conditions; 2) Clinical diagnosis suggests diabetic kidney disease (DKD) or the presence of other kidney diseases; 3) Have not received acupoint plaster therapy or taken other traditional Chinese medicine or proprietary Chinese medicine with similar components and therapeutic effects to "Yishen Huoxue Prescription" within the past 12 months; 4) Have experienced severe infections severe anemia electrolyte disturbances or other complications within the past 4 weeks; 5) Accompanying acute kidney injury oliguria or anuria severe edema large pleural effusions or ascites; 6) Have had severe heart brain liver and hematopoietic system diseases within the past three months: stroke transient ischemic attack significant neurological dysfunction remaining after stroke myocardial infarction unstable angina ischemic heart disease with coronary artery bypass or PCI surgery congestive heart failure (NYHA class III-IV) transaminase leve

Design outcomes

Primary

MeasureTime frame
Diabetic Kidney Disease (DKD) Incidence;Renal function level;Albuminuria level;

Secondary

MeasureTime frame
ELISA detection of kidney - damage - related biomarkers nephrin;blood rheology testing;ELISA detection of kidney - damage - related biomarkers podocin;multimodal biometric monitoring;ELISA detection of kidney - damage - related biomarkers: klotho;

Countries

China

Contacts

Public ContactLiu Hongfang

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

lhfdoctor@126.com18811181809

Outcome results

None listed

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