A randomised controlled trial examining the effects of Traditional Chinese Medicinal Shenzhuo formula on clinical proteinuria periord in diabetic kidney disease

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-ICR-15006311

Enrollment

Unknown

Registered

2015-04-27

Start date

2015-05-01

Completion date

Unknown

Last updated

2021-11-02

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

Conditions

diabetic kidney disease

Interventions

TCM group:Traditional Chinese Medicinal Shenzhuo formula

Irbesartan group:Irbesartan capsules

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients must meet the diagnostic standard of Western Medicine on clinical proteinuria periord in diabetic kidney disease; 2. Patients must meet Traditional Chinese Medicinal vital energy defficiency and blood stasis syndrome; 3. To be aged 18 to 80 years; 4. Subjects must be informed details of the trail and sign the informed consent; 5. HBA1C <= 8.0%; 6. 0.5g < 24h urinary protein <= 3g; 7. Scr <= 133ummol/l; 8. BP <= 140/90mmHg.

Exclusion criteria

Exclusion criteria: 1. T1DM; 2. Patients whose blood glucose is not smooth, HbA1C > 8%; 3. Patients who has taken isokalaemic diuretic; 4. Patients with severe anemia, hemoglobin < 59g/L; 5. Serum-albumin < 35g/L; 6. Severe cardiovascular disease comorbidities; 7. Non-diabetes-induced kidney disease,such as drug induced renal damage, IgA kidney desease, high uric acid nephropathy and so on; 8. Pregnancy,lactation,planned pregnancy and non-contraception women; 9. Allergic to Traditional Chinese Medicine or ACEIs or allergic constitution; 10. Metal disorders; 11. Participated in other clinical trials within the past one month and be participating in other clinical trials; 12. According to the researcher's judgment,patients who may reduce the inclusion rate or complicate the inclusion, like having changing work place, unstable living environment and other situations causing lost of following-up; 13. Patients with liver function damage (ALT or AST more than 2.5 times the upper limit of normal value).

Design outcomes

Primary

Measure	Time frame
24h urinary protein;	—

Secondary

Measure	Time frame
eGFR;the symptom integral of traditional Chinese Medicine;	—

Countries

China

Contacts

Public ContactXiaolin Tong

Guanganmen Hospital, China Academy of Chinese Medical Sciences

xiaolingtong66@sina.com+86 010-88001166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 7, 2026