Traditional Chinese Patent Medicine Qizhijiangtang Capsule for Non-Proliferative Diabetic Retinopathy: Study Protocol for a Randomized Controlled Trial

Pang B1#, Guo H1#, Zhang YY1#, Feng S2, Hu HJ3, Sun Y4, Cao AM5, Lu CQ6, Zhang WH7 and Ni Q1*

1Department of Endocrinology, Guang’anmen Hospital of China Academy of Chinese Medical Sciences, Beijing,
China
2China Academy of Chinese Medical Sciences, Guang’amen Hospital Southern District, Beijing, China
3Department of Endocrinology, Beijing Shunyi District Hospital of Chinese Medicine, Beijing, China
4Department of Endocrinology, Beijing Pinggu District Hospital of Chinese Medicine, Beijing, China
5Department of Endocrinology, Beijing Changping District Hospital of Chinese Medicine, Beijing, China
6Department of Endocrinology, Beijing Miyun District Hospital of Chinese Medicine, Beijing, China
7Department of Endocrinology, Beijing Shijitan Hospital, Capital Medical University, Beijing, China
#These authors contributed equally to this work

^*Correspondance to: Qing Ni 

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Abstract:

Background: Diabetic retinopathy remains a leading cause of vision loss globally. Here, we investigated the efficacy and safety of Qizhijiangtang Capsule (QZJC), a kind of traditional Chinese patent medicine, for patients with NPDR. Methods: This study is a multi-center, randomized, controlled clinical trial. A total of 100 participants will be randomly assigned in a 1:1 ratio to QZJC group or QZJC placebo group. The treatment duration lasts 24 weeks. The primary outcome is the changes in the degree of retinal microaneurysm lesions assessed by fundus photography and fundus fluorescence angiography before and after treatment. The secondary outcomes include the changes in corrected visual acuity, blood glucose, glycosylated hemoglobin, urinary microalbumin excretion rate, the improvement of TCM syndromes and TCM symptoms. Discussion: We postulate that NPDR patients will benefit from QZJC. If successful, this work will provide preliminary evidence that QZJC could delay the progress of DR. Trial registration: Chinese Clinical Trial Registry no. ChiCTR1900023506.

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Cite the Article:

Pang B, Guo H, Zhang YY, Feng S, Hu HJ, Sun Y, et al. Traditional Chinese Patent Medicine Qizhijiangtang Capsule for Non-Proliferative Diabetic Retinopathy: Study Protocol for a Randomized Controlled Trial. Ann Clin Case Rep. 2022; 7: 2340.