Efficacy and Safety of TangWang Prescription for Type 2 Non-Proliferative Diabetic Retinopathy: A Study Protocol for a Randomized Controlled Trial

De Jin, Yuehong Zhang, Yuqing Zhang, Wenjing Huang, Xiang Meng, Fan Yang, Qi Bao, Meizhen Zhang, Yanan Yang, Qing Ni, Fengmei Lian, Xiaolin Tong, De Jin, Yuehong Zhang, Yuqing Zhang, Wenjing Huang, Xiang Meng, Fan Yang, Qi Bao, Meizhen Zhang, Yanan Yang, Qing Ni, Fengmei Lian, Xiaolin Tong

Abstract

Background: Diabetic retinopathy (DR) is one of the most common and severe microvascular complications of diabetes mellitus (DM), which results in blindness among adults worldwide. Presently, the efficacy of drug treatments for diabetic retinopathy (DR) is not satisfactory, thus urgently necessitating effective drug treatment measures. TangWang prescription (TWP) has been found to have retinal protection effects in previous clinical and basic research. However, there is a lack of rigorous, randomized, and controlled studies. This study aims to evaluate the efficacy and safety of TWP in delaying the development of DR. Methods: This study is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial, consisting of 384 participants to be randomized in a 1:1 ratio in the treatment and control groups. Furthermore, the treatment and control groups will be administered the TangWang prescription and the placebo, respectively, each at a dose of one bag twice a day. The study period will last for 48 weeks. The primary outcome measure will be the changes in the degree of retinal microvascular lesions before and after treatment. The secondary outcome will be changes in the degree of hemangioma, microvascular bleeding, microvascular leakage, macular edema, and vision. All statistical tests will be two-sided, and a p < 0.05 will be considered statistically significant. Discussion: We hypothesize that the patients with DR will benefit from TangWang prescription, and in addition to the central random system and platform of dynamic information collection, the patients' conditions will be monitored, and the data collected for analysis. If successful, this study will provide evidence that the TWP formulation delays in the progression of DR. Trial registration: The design of this trial has been registered with the ClinicalTrials.gov (NCT03025399).

Keywords: TangWang prescription; diabetic retinopathy; protocol; randomized controlled trial; traditional chinese medicine.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The reviewer YS declared a shared affiliation, with no collaboration, with the authors XM and YF to the handling Editor.

Copyright © 2021 Jin, Zhang, Zhang, Huang, Meng, Yang, Bao, Zhang, Yang, Ni, Lian and Tong.

Figures

FIGURE 1
FIGURE 1
The trial schematic flow.

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