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Multicenter, Prospective, Real-World Study on the Treatment of Diabetic Retinopathy with Tongluo Mingmu Capsules

Multicenter, Prospective, Real-World Study on the Treatment of Diabetic Retinopathy with Tongluo Mingmu Capsules

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026001393
Enrollment
Unknown
Registered
2026-06-03
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-06-22

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:Conventional treatment with the addition of Tongluo Mingmu Capsules
Control group:Conventional treatment

Sponsors

Shijiazhuang Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75 years (inclusive); (2) Meet the diagnostic criteria for type 2 diabetic retinopathy with blood stasis obstructing the collaterals, and deficiency of both Qi and Yin; (3) Diagnosed by examination as non-proliferative diabetic retinopathy (NPDR) stages I-III; (4) Voluntarily participate, understand, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Self-reported history of retinal laser photocoagulation treatment or suitability for photocoagulation treatment; (2) Self-reported other eye diseases, such as glaucoma, non-diabetic retinopathy, uveitis, retinal detachment, optic nerve diseases, or high myopia; (3) Patients with cataracts and vision 2.0×ULN (upper limit of normal); (5) Allergic to the components of the investigational drug; (6) Pregnant women, women planning pregnancy, or women who are breastfeeding; (7) Participated in other clinical trials in the past three months; (8) Participants whom the investigator considers to have potential risks or other factors making them unsuitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Change in corrected vision from baseline after 24 weeks of treatment;

Secondary

MeasureTime frame
Changes in the Staging of DR Retinopathy;Changes in the number of retinal hemorrhages and microaneurysms compared to baseline;Changes in intraocular pressure;

Countries

China

Contacts

Public ContactChunli Chen,Junhong Duan,Juan Wang

Shijiazhuang Hospital of Traditional Chinese Medicine

736104273@qq.com13331398307

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026