Dry eye disease (DED) is one of the most prevalent ocular surface disorders, affecting millions of people worldwide1 with a reported prevalence of up to 50%2. DED significantly affects quality of vision, mental health, daily activities, professional work, and quality of life2. With the increasing use of electronic products and the rapid aging process, DED has become a severe public health concern.

Several treatments have been clinically used for DED; however, no cure is currently available. Mainstream drugs include artificial tear drops, corticosteroids and anti-inflammatory, and immunosuppressive drugs. Artificial tear drops are palliative in nature, and the long-term use of anti-inflammatory drugs, corticosteroids, and immunosuppressive drugs can cause side effects3. Thus, there remains an unmet need for an effective and well-tolerated treatment for DED. Traditional Chinese medicine (TCM) has received increasing attention owing to its minor side effects. Based on the theory of “syndrome differentiation and treatment,” DED is recorded as “ShenShuiJiangKu” or “BaiSeZheng.” DED is mainly caused by dysfunction of internal organs, leading to an increased consumption of body fluid and a deficiency of “Yin,” subsequently resulting in dry eye. Previous studies have shown that Ophiopogonis Radix have the effect of nourishing Yin4,5, and the use of Rehmanniae Radix could promote tear secretion and stabilize the tear film6. Lycii Fructus is also reported to reduce the ocular surface inflammatory response and improve the symptoms of DED7. Based on the analysis of ancient and modern prescriptions for DED, researchers invented a novel prescription termed Jiejing Runmu decoction, prepared using Maidong, Xuanshen, Shengdi, Gouqi, Bohe, Gancao, Sangye, Huangqin, Juhua/Yejuhua, and Renshen. Jiejing Runmu means nourishing and making the eyes moist. This study aimed to investigate the effectiveness and safety of Jiejing Runmu decoction in relieving the clinical manifestation of DED, thereby exploring novel therapeutic methods for DED treatment.