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
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 13
- 主要终点
- diabetic retinopathy(DR)progression rate
研究概览
简要总结
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.
详细描述
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.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the diagnosis of type 2 diabetes.
- •Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
- •Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
- •Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
- •HbA1C ≤ 9%.
- •Age between 18 and 75 years old
- •Informed consent, voluntary subject. The process of obtaining informed consent form complies with Good Clinical Practice(GCP).
排除标准
- •Patient with the diagnosis of diabetic retinopathy is combined with severe vitreous blood effusion, or required total retinal laser treatment or vitrectomy.
- •Patient who has been treated with full retinal laser photocoagulation.
- •Patient with difficulty in evaluating fundus images with refractive medium turbidity.
- •Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
- •Patient with other serious diabetes complications, such as diabetes gangrene.
- •Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
- •Female patient with pregnancy, or prepare for pregnancy, or lactating.
- •Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
- •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.
- •Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
- •Patient participated in other clinical researches within a month.
研究组 & 干预措施
Tangningtongluo tablets
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.
干预措施: Tangningtongluo tablets (Drug)
Calcium dobesilate capsules
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.
干预措施: Calcium dobesilate capsules (Drug)
结局指标
主要结局
diabetic retinopathy(DR)progression rate
时间窗: At 24 weeks
Using ETDRS Classification to evaluate DR Progress rate
Best corrected vision acuity (BCVA)
时间窗: At 24 weeks
using ETDRS vision chart measure vision change from Baseline
次要结局
- Fundus photography(At 12, 24weeks)
- Retinal blood oxygen saturation(At 12, 24weeks)
- HbA1c(At 12,24,36 and 48 weeks)
- Efficacy of traditional Chinese medicine syndrome.(At 12, 24 and 48 weeks)
- Retinal macular optical coherence tomography angiography (OCTA)(At 12, 24weeks)
- Routine eye examination;(At 4,8,12, 24,36 and 48 weeks)