Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

Guizhou Bailing Group Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Type2 Diabetes; Diabetic Retinopathy

Treatments: Drug: Tangningtongluo tablets; Drug: Calcium dobesilate capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT05007262

TNTL-21-01

Details and patient eligibility

About

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.

Full 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.).

Enrollment: 240 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Patients with the diagnosis of type 2 diabetes.
• 2. Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
• 3. Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
• 4. Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
• 5. HbA1C ≤ 9%.
• 6. Age between 18 and 75 years old
• 7. Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP).

Exclusion criteria

• 1. Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy.
• 2. Patient who has been treated with full retinal laser photocoagulation.
• 3. Patient with difficulty in evaluating fundus images with refractive medium turbidity.
• 4. Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
• 5. Patient with other serious diabetes complications, such as diabetes gangrene.
• 6. Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
• 7. Female patient with pregnancy, or prepare for pregnancy, or lactating.
• 8. Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
• 9. Liver and renal function (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 x Upper limit of normal (ULN)and Cr> above 1 x Upper limit of normal (ULN)). The diabetic nephropathy stage was 4 and above.
• 10. Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
• 11. Patient participated in other clinical researches within a month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Tangningtongluo tablets

Experimental group

Description:

Tangningtongluo tablets, 4 tablets one time,tid,po, taken after meals.The patients will receive drugs for 24 weeks continuously. After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI） and Angiotensin Receptor Blocker（ARB） drugs will be continued to use as the original treatment protocol.

Treatment:

Drug: Tangningtongluo tablets

Calcium dobesilate capsules

Active Comparator group

Description:

Calcium dobesilate capsules, 1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.After 24 weeks, the researchers will decide whether to continue depend on the patient condition and willingness. The maximum medication time is up to 48 weeks.Basic treatment: According to the comprehensive objectives of China Type 2 Diabetes Guidelines (2020 Edition) .The Angiotensin-Converting Enzyme（ACEI ）and Angiotensin Receptor Blocker （ARB） drugs will be continued to use as the original treatment protocol.

Treatment:

Drug: Calcium dobesilate capsules