Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Retinopathy; Type2 Diabetes
• Intervention / Treatment: Drug: Tangningtongluo tablets; Drug: Calcium dobesilate capsules

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400011
      • Chongqing Hospital of Traditional Chinese Medicine
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Gansu Provincial Hospital of Traditional Chinese Medicine
  • Guizhou
    • Anshun, Guizhou, China, 561099
      • People'S Hospital of Anshun City Guizhou Province
    • Guiyang, Guizhou, China, 550003
      • The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine
  • Hebei
    • Shijiazhuang, Hebei, China, 050013
      • Hebei Provincial Hospital of Traditional Chinese Medicine
  • Hunan
    • Changsha, Hunan, China, 410021
      • The First Hospital of Hunan University of Chinese Medicine
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 750306
      • Inner Mongolia Hospital of traditional Chinese Medicine
  • Jiangshu
    • Nantong, Jiangshu, China, 226006
      • Affiliated Hospital of Nantong University
    • Yangzhou, Jiangshu, China, 225012
      • Yangzhou Hospital of Traditional Chinese Medicine
  • Sichuan
    • Chengdu, Sichuan, China
      • Ineye Hospital of Chendu University of TCM
    • Chongqing, Sichuan, China
      • Banan Hospital Affiliated to Chongqing Medical University
  • Yunnan
    • Honghe Prefecture, Yunnan, China
      • South Central Hospital of Yunnan Province
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • Eye Hospital of WMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected vision acuity (BCVA)	using ETDRS vision chart measure vision change from Baseline	At 24 weeks
diabetic retinopathy(DR)progression rate	Using ETDRS Classification to evaluate DR Progress rate	At 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guizhou Bailing Group Pharmaceutical Co Ltd
• Investigators: Principal Investigator: Junguo Duan, professor, Ineye Hospital of Chendu University of TCM

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Anticipated): October 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 5, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Retinopathy; Tangningtongluo tablets
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Hemostatics; Coagulants; Calcium; Calcium Dobesilate
• Other Study ID Numbers: TNTL-21-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No