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

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).

Clinical observations and mechanistic insights of traditional Chinese medicine in the management of diabetic retinopathy

“…Similar positive outcomes were observed with the Zi-Yin-Yi-Qi-Tong-Luo Formula (Jia 2014 ) and the Tang-Wang Presentation (Jin et al. 2021 ) in treating Type 2 NPDR.…”

Diosgenin: An ingress towards solving puzzle for diabetes treatment

“…The condition in which loss of vision due to diabetes severity is normally recognized as diabetic retinopathy (Rajalakshmi et al, 2022). The severity of the case is generally measured by damage caused by diabetic retinopathy along with the presence of macular edema which could be followed by a suitable line of treatment (Jin et al, 2021). Diabetic retinopathy is also causing cataract which is caused by the aldose reductase (AR) enzyme (Bhadada et al, 2016).…”

Oral Chinese medicines for treating diabetic macular edema: Protocol for a systematic search of randomized studies and meta-analysis

“…In Chinese medicine, DME is described as the "thirsty eye disease", a disorder characterized by blood stasis and Qi deficiency [36]. Oral TCMs inhibit inflammation, improve microcirculation, reduce angiogenesis, enhance immune activities and regulate glucose metabolism [37][38][39]. For example, isoflavones in Pueraria lobata inhibit aldose reductase activity, reduce sorbitol pathway activity and lower blood glucose levels [40][41][42].…”