Study of Evaluation on the Clinical Efficacy of Tradition Chinese Medcine in the treatment of Non-proliferative diabetic retinopathy

Study of Evaluation on the Clinical Efficacy of Individualized Syndrome

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-11001220

Enrollment

Unknown

Registered

2011-03-11

Start date

2009-10-01

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

Non-proliferative diabetic retinopathy

Interventions

TCM vs placebo:Formula of T.C.M: benefit qi nourish Yin formula (granule ), 4.5g, oral, tid. Placebo:simulation formula(granule), 4.5g, oral, tid.

method:Method:1.The period of alternate treatment uses the formula of T.C.M and placebo itself before and after cross-over study design. Each patient will receive two treatment matching cycle .The tim

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria of diabetic mellitus; 2. Meet the diagnostic criteria of non-proliferative diabetic retinopathy, and belongs to light and medium stage of the disease(with ETDRS visual chart); 3. Meet the diagnostic criteria of TCM syndrome patients; 4. Patient who is 35-75 years old; 5. All voluntary cases were informed consent and abide by GCP during trial procedure.

Exclusion criteria

Exclusion criteria: 1. Severe non-proliferative or proliferative diabetic retinopathy; 2. Failure to evaluate eye image of the tested eye with severe opacity of refractive media; 3. With diabetic ketoacidosis and other acute metabolic disorders or severe acute infection in recent one month; 4. Combined with the other serious complications of diabetes; 5. The person who allergic to drugs, food, pollen and other allergies, or is allergic corporeity; 6. Prepare gravid, pregnancy or lactating women; 7. With severe primary diseases such as cardiovascular, liver or kidney disease, or hematopoietic system disease; 8. With other eye diseases sush as glaucoma, uveitis, optic neuropathy and severe cataract.

Design outcomes

Primary

Measure	Time frame
1.Vision;2.Eye fundus photograph;3.Visual electro physiology examination:FERG?OPs;4. Syndrome factor;	—

Secondary

Measure	Time frame
1. Syndrome factor scale of T.C.M;2.Subjective symptom;3.Vision;4.Eye fundus examination;	—

Countries

China

Contacts

Public ContactXuejing Lu

luxgen@sohu.com+86 13980994321

Outcome results

None listed

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