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

NCT ID: NCT03025399

Last Updated: 2017-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 384 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2020-05-31

Brief Summary

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.

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.

Conditions

Diabetic Non-proliferative Retinopathy; Type2 Diabetes

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Tangwang prescription

Intervention Type: DRUG

A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.

Interventions

Tangwang prescription

A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.

Intervention Type: DRUG

Placebo

Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.

Intervention Type: DRUG

Other Intervention Names

Tang Wang Fang; Placebos

Eligibility Criteria

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；

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Hubei Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Zhengzhou City Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Baodin City Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

zi bo wanjie cancer hospital

UNKNOWN

Sponsor Role: collaborator

Shijiazhuang City Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Zouping Country Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Fengmei Lian

OTHER

Sponsor Role: lead

Responsible Party

Fengmei Lian

Chief

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Fengmei Lian, PHD

Role: CONTACT

lfm565@sohu.com

0086-010-88001402

References

Jin D, Zhang Y, Zhang Y, Huang W, Meng X, Yang F, Bao Q, Zhang M, Yang Y, Ni Q, Lian F, Tong X. Efficacy and Safety of TangWang Prescription for Type 2 Non-Proliferative Diabetic Retinopathy: A Study Protocol for a Randomized Controlled Trial. Front Pharmacol. 2021 Mar 15;12:594308. doi: 10.3389/fphar.2021.594308. eCollection 2021.

Reference Type: DERIVED

PMID: 33790783 (View on PubMed)

Other Identifiers

2015Tangwang Prescription

Identifier Type: -

Identifier Source: org_study_id