Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine | OTHER |
| Hubei Hospital of Traditional Chinese Medicine |
Not provided
Not provided
Not provided
Not provided
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.
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.
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.
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.
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:
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).
The provisions of the combined therapy
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tangwang Prescription | Experimental | The prescription was composed five Chinese herbal medicines,every bag has 4.87g granules, take it one bag each time, two times a day. |
|
| Placebo | Placebo Comparator | Placebo is a simulated drug of tangwang Prescription,every bag has 4.87g granules, take it one bag each time, two times a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tangwang prescription | Drug | A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules. |
|
| Measure | Description | 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) | 0 week, 24 weeks, 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the number of micro hemangioma of diabetic retinopathy | 0 week, 24 weeks, 48 weeks | |
| Change of the number of microvascular bleeding of diabetic retinopathy | Color fundus photography and fundus fluorescein angiography were performed |
Not provided
Inclusion Criteria:
Diagnosis of diabetic retinopathy、the degree of disease was non-proliferative diabetic retinopathy;
Age at 30-70 years old;
Signed the informed consent;
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fengmei Lian, PHD | Contact | 0086-010-88001402 | lfm565@sohu.com |
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33790783 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Zhengzhou City Hospital of Traditional Chinese Medicine | OTHER |
| Baodin City Hospital of Traditional Chinese Medicine | UNKNOWN |
| zi bo wanjie cancer hospital | UNKNOWN |
| Shijiazhuang City Hospital of Traditional Chinese Medicine | UNKNOWN |
| Zouping Country Hospital of Traditional Chinese Medicine | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility. |
|
|
| 0 week, 24 weeks, 48 weeks |
| Change of the number of microvascular leakage of diabetic retinopathy | 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 | 0 week, 24 weeks, 48 weeks |
| Change of Vision (analysis of visual acuity before and after medication using EDTRS international visual acuity chart) | 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 |