NCT05007262

Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

Clinical Study on the Efficacy and Safety of Tangningtongluo Tablet in Treating Non Proliferative Diabetic Retinopathy - The Syndrome of Yin Asthenia Generating Intrinsic Heat and Eye Collateral Stasis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is planned to collect relevant clinical data to evaluate the prevention efficacy and safety of Tangningtongluo tablets on the non-proliferation period of diabetic retinopathy.

Detailed description

After being informed about the study and potential risks,all patients giving written informed consent will undergo a 1-week screening period to eligibility for study entry.At week 0,patients who meet the eligibility requirements will be randomized into two groups(experimental group and control group)in a 1:1 ratio to Tangningtongluo tablets(4 tablets,tid,po.) or Calcium dobesilate capsules(1 capsule,tid,po.).

Conditions

• Type2 Diabetes
• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Tangningtongluo tablets	Four pills each time and three times a day after meals.
DRUG	Calcium dobesilate capsules	1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.

Timeline

• Start date: 2021-08-31
• Primary completion: 2023-10-31
• Completion: 2023-12-31
• First posted: 2021-08-16
• Last updated: 2023-05-09

Locations

13 sites across 1 country: China