Back to resultsTangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy
Primary Purpose
Type2 Diabetes, Diabetic Retinopathy
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tangningtongluo tablets
Calcium dobesilate capsules
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes focused on measuring Diabetes, Retinopathy, Tangningtongluo tablets
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.
Sites / Locations
- Chongqing hospital of traditional Chinese Medicine
- Gansu Provincial Hospital of traditional Chinese Medicine
- People's Hospital of Anshun City Guizhou Province
- The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
- Hebei Provincial Hospital of traditional Chinese Medicine
- The First Hospital of Hunan University of Chinese Medicine
- Inner Mongolia Hospital of traditional Chinese Medicine
- Affiliated Hospital of Nantong University
- Yangzhou Hospital of traditional Chinese Medicine
- Ineye Hospital of Chendu University of TCM
- Banan Hospital Affiliated to Chongqing Medical University
- South Central Hospital of Yunnan Province
- Eye Hospital of WMU
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tangningtongluo tablets
Calcium dobesilate capsules
Arm 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.
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.
Outcomes
Primary Outcome Measures
Best corrected vision acuity (BCVA)
using ETDRS vision chart measure vision change from Baseline
diabetic retinopathy(DR)progression rate
Using ETDRS Classification to evaluate DR Progress rate
Secondary Outcome Measures
Fundus photography
quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.
Retinal blood oxygen saturation
measure retinal blood oxygen saturation
Retinal macular optical coherence tomography angiography (OCTA)
measure macular vascular density, retinal thickness, retinal volume;
HbA1c
Measure the patient's HbA1c
Routine eye examination;
Including the examination of cornea, lens, anterior chamber, iris, etc
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.
Full Information
NCT ID
NCT05007262
First Posted
August 5, 2021
Last Updated
May 8, 2023
Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05007262
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, Diabetic Retinopathy
Keywords
Diabetes, Retinopathy, Tangningtongluo tablets
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tangningtongluo tablets
Arm Type
Experimental
Arm 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.
Arm Title
Calcium dobesilate capsules
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Tangningtongluo tablets
Intervention Description
Four pills each time and three times a day after meals.
Intervention Type
Drug
Intervention Name(s)
Calcium dobesilate capsules
Intervention Description
1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.
Primary Outcome Measure Information:
Title
Best corrected vision acuity (BCVA)
Description
using ETDRS vision chart measure vision change from Baseline
Time Frame
At 24 weeks
Title
diabetic retinopathy(DR)progression rate
Description
Using ETDRS Classification to evaluate DR Progress rate
Time Frame
At 24 weeks
Secondary Outcome Measure Information:
Title
Fundus photography
Description
quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.
Time Frame
At 12, 24weeks
Title
Retinal blood oxygen saturation
Description
measure retinal blood oxygen saturation
Time Frame
At 12, 24weeks
Title
Retinal macular optical coherence tomography angiography (OCTA)
Description
measure macular vascular density, retinal thickness, retinal volume;
Time Frame
At 12, 24weeks
Title
HbA1c
Description
Measure the patient's HbA1c
Time Frame
At 12,24,36 and 48 weeks
Title
Routine eye examination;
Description
Including the examination of cornea, lens, anterior chamber, iris, etc
Time Frame
At 4,8,12, 24,36 and 48 weeks
Title
Efficacy of traditional Chinese medicine syndrome.
Description
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.
Time Frame
At 12, 24 and 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junguo Duan, professor
Organizational Affiliation
Ineye Hospital of Chendu University of TCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chongqing hospital of traditional Chinese Medicine
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400011
Country
China
Facility Name
Gansu Provincial Hospital of traditional Chinese Medicine
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730050
Country
China
Facility Name
People's Hospital of Anshun City Guizhou Province
City
Anshun
State/Province
Guizhou
ZIP/Postal Code
561099
Country
China
Facility Name
The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550003
Country
China
Facility Name
Hebei Provincial Hospital of traditional Chinese Medicine
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050013
Country
China
Facility Name
The First Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410021
Country
China
Facility Name
Inner Mongolia Hospital of traditional Chinese Medicine
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
750306
Country
China
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangshu
ZIP/Postal Code
226006
Country
China
Facility Name
Yangzhou Hospital of traditional Chinese Medicine
City
Yangzhou
State/Province
Jiangshu
ZIP/Postal Code
225012
Country
China
Facility Name
Ineye Hospital of Chendu University of TCM
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Banan Hospital Affiliated to Chongqing Medical University
City
Chongqing
State/Province
Sichuan
Country
China
Facility Name
South Central Hospital of Yunnan Province
City
Honghe Prefecture
State/Province
Yunnan
Country
China
Facility Name
Eye Hospital of WMU
City
Wenzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy
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