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Type2 DiabetesPhase 2NCT05007262

Tangningtongluo Tablet in the Treatment of Non-proliferative Diabetic Retinopathy

A Phase 2 study testing Tangningtongluo tablets and Calcium dobesilate capsules in people with Type2 Diabetes and Diabetic Retinopathy, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 13 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type2 Diabetes, Diabetic Retinopathy
What is being tested?
Tangningtongluo tablets and Calcium dobesilate capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
13 sitesChina
Study dates
31 Aug 2021to 31 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • People's Hospital of Anshun City Guizhou Province

    Anshun, Guizhou, 561099

  • The First Hospital of Hunan University of Chinese Medicine

    Changsha, Hunan, 410021

  • Ineye Hospital of Chendu University of TCM

    Chengdu, Sichuan

  • Chongqing hospital of traditional Chinese Medicine

    Chongqing, Chongqing Municipality, 400011

  • Banan Hospital Affiliated to Chongqing Medical University

    Chongqing, Sichuan

  • The Second Affiliated Hospital of Guizhou University of traditional Chinese Medicine

    Guiyang, Guizhou, 550003

  • Inner Mongolia Hospital of traditional Chinese Medicine

    Hohhot, Inner Mongolia, 750306

  • South Central Hospital of Yunnan Province

    Honghe Prefecture, Yunnan

  • Gansu Provincial Hospital of traditional Chinese Medicine

    Lanzhou, Gansu, 730050

  • Affiliated Hospital of Nantong University

    Nantong, Jiangshu, 226006

  • Hebei Provincial Hospital of traditional Chinese Medicine

    Shijiazhuang, Hebei, 050013

  • Eye Hospital of WMU

    Wenzhou, Zhejiang

  • Yangzhou Hospital of traditional Chinese Medicine

    Yangzhou, Jiangshu, 225012

Other trials in China

About this study

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

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.

Read the 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.).

Being tested
Tangningtongluo tablets, Calcium dobesilate capsules
Keywords
Diabetes, Retinopathy, Tangningtongluo tablets
Medical subject headings
Diabetic Retinopathy, Diabetes Mellitus, Retinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tangningtongluo tabletsDrug

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

  • Calcium dobesilate capsulesDrug

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

Study groups in NCT05007262
Study groupRoleWhat they receive
Tangningtongluo tabletsExperimentalTangningtongluo 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.
Receives: Drug: Tangningtongluo tablets
Calcium dobesilate capsulesActive comparatorCalcium 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.
Receives: Drug: Calcium dobesilate capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best corrected vision acuity (BCVA)

    using ETDRS vision chart measure vision change from Baseline

    Measured: At 24 weeks

  2. diabetic retinopathy(DR)progression rate

    Using ETDRS Classification to evaluate DR Progress rate

    Measured: At 24 weeks

Secondary outcomes (6)

  1. Fundus photography

    quantitative analysis of fundus microhemangioma, bleeding, exudation, and tube diameter.

    Measured: At 12, 24weeks

  2. Retinal blood oxygen saturation

    measure retinal blood oxygen saturation

    Measured: At 12, 24weeks

  3. Retinal macular optical coherence tomography angiography (OCTA)

    measure macular vascular density, retinal thickness, retinal volume;

    Measured: At 12, 24weeks

  4. HbA1c

    Measure the patient's HbA1c

    Measured: At 12,24,36 and 48 weeks

  5. Routine eye examination;

    Including the examination of cornea, lens, anterior chamber, iris, etc

    Measured: At 4,8,12, 24,36 and 48 weeks

  6. 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.

    Measured: At 12, 24 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2021
  2. Study start31 Aug 2021
  3. Primary completion31 Oct 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05007262
Sponsor's protocol ID
TNTL-21-01
Status last verified
Apr 2023
First submitted
5 Aug 2021
Last updated
9 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tangningtongluo tablets and Calcium dobesilate capsules in people with Type2 Diabetes and Diabetic Retinopathy, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best corrected vision acuity (BCVA) (time frame: At 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05007262.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.

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