DRDN randomized controlled double-blind multicenter clinical trial with TCM intervention

community-based TCM intervening diabetes and its its application popularization study program” intervention study of diabetic micro-angiopathy”-- DR?DN randomized controlled double-blind multicenter clinical trial with TCM intervention

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002953

Enrollment

Unknown

Registered

2012-12-23

Start date

2011-01-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

diabetic micro-angiopathy

Interventions

TCM:Qiming granule

Control:Placebo

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients corresponding to diabetes mellitus diagnostic criteria; 2. moderate nonproliferative diabetic retinopathy through severe nonproliferative diabetic retinopathy according to international classification criteria; 3. patients with diabetic nephropathy in phase II, III, IV; 4. corrected visual acuity 20/125 or better in ETDRS chart; 5.patients corresponding to TCM symdrome diagnosis criteria; 6. HbA1C<=9.0%; 7. aged from 35 to 75; 8. volunteer subjects sign the informed consent form according to the GCP provision.

Exclusion criteria

Exclusion criteria: 1. proliferative diabetic retinopathy; 2. eyes having been treated with panretinal photocoagulation; 3. refractive medium turbidity that is difficult to have the fundus evaluation; 4. inspection confirmed that the nephropathy is caused by systemic disease like primary hypertension; 5. He/she is allergic to the known constituents of experimental drugs or allergic physical; 6. Patients combined with sever disease like severe heart disease(chronic heart failure ranked in New York Heart Association class 3 or above\severe arrhythmia), abnormal liver tests (AST\ALT>=1.5 times the upper limit of normal) and hematopoietic system(above middle pitch of anemia), psychopath; 7. Patients with severe ocular disease as glaucoma, uveitis, age-related macular degeneration and optic neuropathy; 8. Patients allergic to drugs, food, pollen or allergic physical; 9. women prepare to be pregnant, pregnant or lactating; 10. Patients with urologic disease like glomerulonephritis, idiopathic nephrotic syndrome, urinary tract infection, obstruction; 11. Patients with severe infections, diabetic ketoacidosis, hyperkalemia; 12. People participate in other clinical trials within 3 months.

Design outcomes

Primary

Measure	Time frame
incidence of proliferative diabetic retinopathy;microalbuminuria of diabetic nephropathy;	—

Secondary

Measure	Time frame
TCM syndromes;urine proteins/ Cr ratio;	—

Countries

China

Contacts

Public ContactDuan Junguo

duanjg@vip.sina.com+86 18980880128

Outcome results

None listed

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