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Study on the effect of Qihuang Mingmu recipe on non-proliferative type 2 diabetic retinopathy

Clinical research on the intervention of Qihuang Mingmu recipe in NPDR based on TGF-ß1/a-SMA signaling pathway

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053595
Enrollment
Unknown
Registered
2021-11-24
Start date
2021-11-12
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

diabetic retinopathy

Interventions

Treatment group:Basic treatment + Qihuang Mingmu Recipe
Control group:Basic treatment

Sponsors

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus patients with stage I-III diabetic retinopathy confirmed by fundus photography or fundus angiography, aged 18-70 years, no gender limit; 2. Blood glucose < 16.7mmol/L, blood pressure <= 140/90mmHg, BMI <= 30kg/m^2 in recent 3 months; 3. Sign the written informed consent; 4. TCM syndrome differentiation is deficiency of both qi and yin, dampness and blood stasis blocking the collaterals.

Exclusion criteria

Exclusion criteria: 1. Those who have fundus vein occlusion, uveitis, age-related macular degeneration, hypertensive retinopathy and other diseases that may cause macular edema, those who have obvious cataracts that affect visual inspection, and those who have glaucoma that affects mydriasis inspection (If the above diseases have only one eye but not the other side, this criterion does not apply). 2. Serious primary system diseases such as respiratory, circulatory, digestive, urinary, neurological, blood, rheumatism, endocrine system diseases and tumors, AIDS, etc. 3. Acute complications of diabetes (diabetic ketoacidosis, diabetic nonketotic hyperosmolar syndrome, etc.), serious chronic complications (such as diabetic nephropathy with nephrotic syndrome, severe diabetic peripheral neuropathy, diabetic lower extremity arterial occlusion, etc.). 4. Allergic constitution or known to be allergic or intolerable to the drugs used in this study. 5. Pregnancy, breastfeeding, mental illness or other patients who may lead to decreased compliance.

Design outcomes

Primary

MeasureTime frame
Incidence, progression and remission of diabetic retinopathy;Vision;

Secondary

MeasureTime frame
Retinal thickness in macular area;Serum TGF-ß1 and a-SMA levels;

Countries

China

Contacts

Public ContactYu Xu

Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

yuxu2017@126.com+86 15951938554

Outcome results

None listed

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