Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

Sponsor

Guizhou Bailing Group Pharmaceutical Co Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05007262

Collaborator

(none)

240

Enrollment

Locations

Arms

18.9

Anticipated Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type2 Diabetes Diabetic Retinopathy	Drug: Tangningtongluo tablets Drug: Calcium dobesilate capsules	Phase 2

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.).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 31, 2021

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Mar 29, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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.

Drug: Tangningtongluo tablets

Four pills each time and three times a day after meals.

Active Comparator: 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.

Drug: Calcium dobesilate capsules

1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.

Outcome Measures

Primary Outcome Measures

Best corrected vision acuity (BCVA) [At 24 weeks]
using ETDRS vision chart measure vision change from Baseline
diabetic retinopathy(DR)progression rate [At 24 weeks]
Using ETDRS Classification to evaluate DR Progress rate

Secondary Outcome Measures

Fundus photography [At 12, 24weeks]
quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.
Retinal blood oxygen saturation [At 12, 24weeks]
measure retinal blood oxygen saturation
Retinal macular optical coherence tomography angiography (OCTA) [At 12, 24weeks]
measure macular vascular density, retinal thickness, retinal volume;
HbA1c [At 12,24,36 and 48 weeks]
Measure the patient's HbA1c
Routine eye examination; [At 4,8,12, 24,36 and 48 weeks]
Including the examination of cornea, lens, anterior chamber, iris, etc
Efficacy of traditional Chinese medicine syndrome. [At 12, 24 and 48 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. Patients with the diagnosis of type 2 diabetes.
1. Patients with the diagnosis of non-proliferative diabetic retinopathy and the classified as mild and moderate.
1. Target eye best corrected vision acuity (BCVA) ≥ 34 points (ETDRS vision chart, vision equivalent of score 20 / 200, decimal 0.1).
1. Patients who meet the syndrome differentiation standards of yin asthenia generating intrinsic heat and eye collateral stasis in traditional Chinese medicine.
1. HbA1C ≤ 9%.
1. Age between 18 and 75 years old
1. 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.
1. Patient who has been treated with full retinal laser photocoagulation.
1. Patient with difficulty in evaluating fundus images with refractive medium turbidity.
1. Patient was diagnosed of acute metabolic disorders such as diabetic ketoacidosis or combined with severe acute infection in the past 1 month.
1. Patient with other serious diabetes complications, such as diabetes gangrene.
1. Patient was allergic to Tangningtongluo tablets, or Calcium dobesilate, or its composition.
1. Female patient with pregnancy, or prepare for pregnancy, or lactating.
1. Patient with serious cardiovascular, liver, kidney or hematopoietic system disease, and mental diseases.
1. 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.
1. Patient with eye diseases such as glaucoma, uveitis, optic neuropathy, and severe cataract.
1. Patient participated in other clinical researches within a month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chongqing hospital of traditional Chinese Medicine	Chongqing	Chongqing	China	400011
2	Gansu Provincial Hospital of traditional Chinese Medicine	Lanzhou	Gansu	China	730050
3	People's Hospital of Anshun City Guizhou Province	Anshun	Guizhou	China	561099
4	The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine	Guiyang	Guizhou	China	550003
5	Hebei Provincial Hospital of traditional Chinese Medicine	Shijiazhuang	Hebei	China	050013
6	The First Hospital of Hunan University of Chinese Medicine	Changsha	Hunan	China	410021
7	Inner Mongolia Hospital of traditional Chinese Medicine	Hohhot	Inner Mongolia	China	750306
8	Affiliated Hospital of Nantong University	Nantong	Jiangshu	China	226006
9	Yangzhou Hospital of traditional Chinese Medicine	Yangzhou	Jiangshu	China	225012
10	Ineye Hospital of Chendu University of TCM	Chengdu	Sichuan	China