Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05007262
• Other study ID #: TNTL-21-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Guizhou Bailing Group Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Type2 Diabetes

Intervention

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

Locations

Country	Name	City	State
China	People's Hospital of Anshun City Guizhou Province	Anshun	Guizhou
China	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan
China	Ineye Hospital of Chendu University of TCM	Chengdu	Sichuan
China	Banan Hospital Affiliated to Chongqing Medical University	Chongqing	Sichuan
China	Chongqing hospital of traditional Chinese Medicine	Chongqing	Chongqing
China	The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine	Guiyang	Guizhou
China	Inner Mongolia Hospital of traditional Chinese Medicine	Hohhot	Inner Mongolia
China	South Central Hospital of Yunnan Province	Honghe Prefecture	Yunnan
China	Gansu Provincial Hospital of traditional Chinese Medicine	Lanzhou	Gansu
China	Affiliated Hospital of Nantong University	Nantong	Jiangshu
China	Hebei Provincial Hospital of traditional Chinese Medicine	Shijiazhuang	Hebei
China	Eye Hospital of WMU	Wenzhou	Zhejiang
China	Yangzhou Hospital of traditional Chinese Medicine	Yangzhou	Jiangshu

Sponsors (1)

Lead Sponsor	Collaborator
Guizhou Bailing Group Pharmaceutical Co Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected vision acuity (BCVA)	using ETDRS vision chart measure vision change from Baseline	At 24 weeks
Primary	diabetic retinopathy(DR)progression rate	Using ETDRS Classification to evaluate DR Progress rate	At 24 weeks
Secondary	Fundus photography	quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.	At 12, 24weeks
Secondary	Retinal blood oxygen saturation	measure retinal blood oxygen saturation	At 12, 24weeks
Secondary	Retinal macular optical coherence tomography angiography (OCTA)	measure macular vascular density, retinal thickness, retinal volume;	At 12, 24weeks
Secondary	HbA1c	Measure the patient's HbA1c	At 12,24,36 and 48 weeks
Secondary	Routine eye examination;	Including the examination of cornea, lens, anterior chamber, iris, etc	At 4,8,12, 24,36 and 48 weeks
Secondary	Efficacy of traditional Chinese medicine syndrome.	It includes the evaluation of the main symptoms such as blurred vision, dry eyes, secondary symptoms such as mental fatigue, shortness of breath and lazy speech, dry mouth and dry throat and etc.	At 12, 24 and 48 weeks