Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

NCT ID: NCT05007262

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2023-12-31

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.).

Conditions

Type2 Diabetes; Diabetic Retinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Tangningtongluo tablets

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Calcium dobesilate capsules

Intervention Type: DRUG

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

Interventions

Tangningtongluo tablets

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

Intervention Type: DRUG

Calcium dobesilate capsules

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guizhou Bailing Group Pharmaceutical Co Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Junguo Duan, professor

Role: PRINCIPAL_INVESTIGATOR

Ineye Hospital of Chendu University of TCM

Locations

Chongqing hospital of traditional Chinese Medicine

Chongqing, Chongqing Municipality, China

Gansu Provincial Hospital of traditional Chinese Medicine

Lanzhou, Gansu, China

People's Hospital of Anshun City Guizhou Province

Anshun, Guizhou, China

The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine

Guiyang, Guizhou, China

Hebei Provincial Hospital of traditional Chinese Medicine

Shijiazhuang, Hebei, China

The First Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, China

Inner Mongolia Hospital of traditional Chinese Medicine

Hohhot, Inner Mongolia, China

Affiliated Hospital of Nantong University

Nantong, Jiangshu, China

Yangzhou Hospital of traditional Chinese Medicine

Yangzhou, Jiangshu, China

Ineye Hospital of Chendu University of TCM

Chengdu, Sichuan, China

Banan Hospital Affiliated to Chongqing Medical University

Chongqing, Sichuan, China

South Central Hospital of Yunnan Province

Honghe Prefecture, Yunnan, China

Eye Hospital of WMU

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

TNTL-21-01

Identifier Type: -

Identifier Source: org_study_id