Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy

January 19, 2017 updated by: Fengmei Lian

Multi Center Clinical Study of Chinese Medicine Intervention on Early Diabetic Microvascular Complications: Multi Centers Clinical Study of Tang Wang Prescription Intervene Diabetic Non-proliferative Retinopathy

This study include 384 Participants with diabetic non-proliferative retinopathy

Design Method: Randomized, double blind, placebo controlled and multicenter clinical study. Participants treatment for 48 weeks, and main aimed to evaluate the therapeutic effect of tang wang prescription improve degree of retinal microvascular disease of patients with diabetic non-proliferative retinopathy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  1. This study is a randomized, double-blinded, placebo-controlled and multicenter clinical trial on type 2 diabetic non-proliferative retinopathy to evaluate the therapeutic effect of tang wang prescription.
  2. Through the calculation of sample size, 384 participants with type 2 diabetic non-proliferative retinopathy will be recruited for the study, all participants were randomly divided into 2 groups, and both of groups would be performed on a basic treatment (including diabetes education, diabetes diet, rational control of blood glucose (oral hypoglycemic agents or insulin injections to keep all participants keep blood glucose stable in the study. If fasting blood glucose fluctuates more than 20%, need to find and remove the factors as soon as possible, and adjust the dose and monitor change of blood glucose, make it smooth in 4 weeks. Adjusted dose of the drug needs to be detailed records in the combined medication table), and oral calcium dobesilate treatment), study group take tang wang prescription, take one bag each time and twice on day, control group take the same dose of placebo.
  3. The study will last for 48 weeks. Once every four weeks follow-up, color fundus photography, fundus fluorescein angiography, and coherent optical tomography were performed every six months; ETDRS international visual acuity test was performed every months.

  4. Curative effect evaluation criteria:

    • Main evaluation criteria: the changes of degree of retinal microvascular lesions before and after treatment, according to the change of degree of retinal microvascular lesions (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase), divided into aggravated, unchanged, reduce three conditions. Aggravated was defined as the degree of retinal microvascular lesions severity more than grade 1 after treatment; unchanged was defined as the degree of retinal microvascular lesions before and after treatment did not change; reduce was defined as the degree of retinal microvascular lesions reduced more than 1 grade after treatment.

    • Second evaluation criteria:

      • Change of the number of micro hemangioma of diabetic retinopathy before and after treatment;
      • Change of the number of microvascular bleeding of diabetic retinopathy before and after treatment;
      • Change of the number of microvascular leakage of diabetic retinopathy before and after treatment;
      • Degree of change of macular edema of diabetic retinopathy before and after treatment;
      • Change of Vision before and after treatment.
  5. Diagnostic and monitoring indicators：blood pressure, fasting blood glucose test (every one month); glycated hemoglobin, blood lipids (every three months); Routine eye examination and fundus examination, including intraocular pressure, anterior segment, lens, vitreous body, and lens, vitreous need describe the conditions of opacity (every six months).

  6. The provisions of the combined therapy

    • All Chinese herbal medicines with the same efficacy as the study drug (including Chinese herbal medicines with similar therapeutic and similar efficacy in Instructions) were banned during the study period.
    • All combined therapy and Combined medication(treatment measure or treatment medicine of other diseases) should be recorded in the combined medication table.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
384

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of diabetic retinopathy、the degree of disease was non-proliferative diabetic retinopathy；
  2. Age at 30-70 years old；

  3. Signed the informed consent；

    • Note: Diabetic retinopathy patients can be selected as the observation object, Who only one eye can meet the inclusion criteria, If both eyes of patient can be selected, please record respectively, and choose one eye to evaluate the curative effect, the eye must according to the following principles: choose the heavier eye as the observation eye, When the fundus conditions of the eyes are in different clinical stages; Select the eye as the eye of clinical manipulation. Choose the eyes with better clinical operation as the observation eyes, When the fundus conditions of the eyes are in same clinical stages.

Exclusion Criteria:

  1. The patients with retinal photocoagulation、appropriate patients for retinal photocoagulation、patient have one or two eyes in diabetic retinopathy proliferative phase、type I diabetes mellitus、there are other eye disease complications(such as glaucoma、cataracts can Significantly interfere the fundus examination、Non - diabetic retinopathy、uveitis、amotio retinae、optic nerve diseases and high myopia with fundus lesions et al.)
  2. Combined with severe primary disease such as cardiovascular、liver、kidney and hematopoietic system et al、the serum transaminase was 2 times larger than the normal valuet、Serum creatinine greater than the upper limit of normal value、Psychiatric patients.
  3. Women with Pregnancy or prepare for pregnancy or lactating.
  4. Patient participated in other clinical researchers within a month.
  5. Patients have been treated with other drugs to treat diabetic retinopathy except for calcium hydroxide within a week.
  6. Systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg.
  7. Patients with diabetic ketosis, ketoacidosis and severe infections within a month
  8. Patients have been alcohol abused and / or used psychoactive substances or drug abused or drug addicted within 5 years.
  9. According to the researcher's judgment, patients have Other lesions or conditions maybe reduce the possibility of entering groups or make the groups complex,such as working environment change frequently、Living environment is unstable what easy to cause loss to follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tangwang Prescription
The prescription was composed five Chinese herbal medicines,every bag has 4.87g granules, take it one bag each time, two times a day.
Drug: Tangwang prescription
A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.
Other Names:
  • Tang Wang Fang
Placebo Comparator: Placebo
Placebo is a simulated drug of tangwang Prescription,every bag has 4.87g granules, take it one bag each time, two times a day.
Drug: Placebo
Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.
Other Names:
  • Placebos

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the changes of degree of retinal microvascular lesions before and after treatment (no, mild non proliferative phase, moderate non proliferative phase, severe non proliferative phase, proliferative phase)
Time Frame: 0 week, 24 weeks, 48 weeks
0 week, 24 weeks, 48 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of the number of micro hemangioma of diabetic retinopathy
Time Frame: 0 week, 24 weeks, 48 weeks
0 week, 24 weeks, 48 weeks
Change of the number of microvascular bleeding of diabetic retinopathy
Time Frame: 0 week, 24 weeks, 48 weeks
Color fundus photography and fundus fluorescein angiography were performed
0 week, 24 weeks, 48 weeks
Change of the number of microvascular leakage of diabetic retinopathy
Time Frame: 0 week, 24 weeks, 48 weeks
0 week, 24 weeks, 48 weeks
Degree of change of macular edema of diabetic retinopathy,analysis of measured values of the shortest distance from the margin of edema and the retinal thickness in macular region before and after medication
Time Frame: 0 week, 24 weeks, 48 weeks
0 week, 24 weeks, 48 weeks
Change of Vision (analysis of visual acuity before and after medication using EDTRS international visual acuity chart)
Time Frame: 0 week, 4 weeks, 8 weeks,12 weeks,16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks
0 week, 4 weeks, 8 weeks,12 weeks,16 weeks, 20 weeks, 24 weeks, 28 weeks, 32 weeks, 36 weeks, 40 weeks, 44 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fengmei Lian

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Hubei Hospital of Traditional Chinese Medicine
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Zhengzhou City Hospital of Traditional Chinese Medicine
Baodin City Hospital of Traditional Chinese Medicine
zi bo wanjie cancer hospital
Shijiazhuang City Hospital of Traditional Chinese Medicine
Zouping Country Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015Tangwang Prescription

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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