Clinical trial NCT05007262: Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Type2 Diabetes
Diabetic Retinopathy
Keywords: Diabetes
Retinopathy
Tangningtongluo tablets
Lead sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.).

Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected vision acuity (BCVA)
timeFrame: At 24 weeks
measure: diabetic retinopathy(DR)progression rate
timeFrame: At 24 weeks
Secondary outcomes:
measure: Fundus photography
timeFrame: At 12, 24weeks
measure: Retinal blood oxygen saturation
timeFrame: At 12, 24weeks
measure: Retinal macular optical coherence tomography angiography (OCTA)
timeFrame: At 12, 24weeks
measure: HbA1c
timeFrame: At 12,24,36 and 48 weeks
measure: Routine eye examination;
timeFrame: At 4,8,12, 24,36 and 48 weeks
measure: Efficacy of traditional Chinese medicine syndrome.
timeFrame: At 12, 24 and 48 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing hospital of traditional Chinese Medicine
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of traditional Chinese Medicine
state: Gansu
city: Anshun
country: China
facility: People's Hospital of Anshun City Guizhou Province
state: Guizhou
city: Guiyang
country: China
facility: The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
state: Guizhou
city: Shijiazhuang
country: China
facility: Hebei Provincial Hospital of traditional Chinese Medicine
state: Hebei
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hohhot
country: China
facility: Inner Mongolia Hospital of traditional Chinese Medicine
state: Inner Mongolia
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangshu
city: Yangzhou
country: China
facility: Yangzhou Hospital of traditional Chinese Medicine
state: Jiangshu
city: Chengdu
country: China
facility: Ineye Hospital of Chendu University of TCM
state: Sichuan
city: Chongqing
country: China
facility: Banan Hospital Affiliated to Chongqing Medical University
state: Sichuan
city: Honghe Prefecture
country: China
facility: South Central Hospital of Yunnan Province
state: Yunnan
city: Wenzhou
country: China
facility: Eye Hospital of WMU
state: Zhejiang
Study officials:
affiliation: Ineye Hospital of Chendu University of TCM
name: Junguo Duan, professor
role: PRINCIPAL_INVESTIGATOR
References: