Objectives: An epidemiologic study in South Korea shows approximately 20% of adults have insomnia. Insomnia Disorder is related to an increased vulnerability to a variety of medical conditions such as cognitive impairment, cardiovascular diseases, psychiatric disorders, and linked to poor academic performance, reduced productivity, an increased risk of traffic accidents. As a result, insomnia can negatively impact one’s quality of life as well as be a significant financial burden of the National Society. Pharmacopuncture is a new type of acupuncture that involves applying herbal medicine extracts to acupuncture points and frequently adopted in Korean medicine. In order to confirm the effectiveness and safety of Pharmacopuncture on Insomnia Disorder, a strategic comparative practical clinical study comparing the effects with active control acupuncture was planned. Methods: This multi-site RCT was conducted at Pusan National University Korean Medicine Hospital, Dong-eui University Korean Medicine Hospital, and Semyung University Korean Medicine Hospital in Chungju. Before trial initiation, protocol was approved by each research institution’s institutional review board (IRB) and was registered with the Clinical Research Information Service (CRIS.nih.go.kr)(KCT0006803). A total of 138 participants with insomnia disorder by 15 or more grade by Insomnia Severity Index (ISI) will be recruited and registered for competitive enrollment. After randomization at 1st visit, the subject will undergo 10 procedures of Pharmacopuncture or Acupuncture during 4 weeks and will final visit after 4 weeks of the last intervention. Since this trial is a pragmatic study that reflects Korean medical clinical practice, in which personalized treatment is provided according to the patient’s clinical status, the types and methods of pharmacopuncture, acupoints, amount of injection, and depth of injection have not been predetermined. However, in this trial, the types of pharmacopuncture are limited to placental, Hwangryunhaedoktang, and Bufonis venenum pharmacopuncture; these are commonly used insomnia treatments in a previous survey. The primary outcome measure will be the mean difference in the total Pittsburgh Sleep Quality Index (PSQI) scores pre- and post-intervention (between visits 1 and 11) between the two groups. The secondary outcomes will be changes in the ISI, PSQI, and visual analog scale (VAS) scores of subjective symptoms accompanying insomnia, and the difference in quantity and quality of sleep recorded using a sleep diary and actigraphy during the trial period. In addition, changes in scores on the Core Seven-Emotions Inventory Short Form (CSEI-S), Pattern Identification Tool Insomnia (PIT-Insomnia), and body composition test between the pre- and post-treatment periods will be analyzed. Quality of life will be measured at the baseline, post-intervention, and follow-up visits using the 5-level EuroQoL-5 dimension, the EuroQol-visual analog scale, the 36-Item Short Form Health Survey, and The Korean Health-Related Quality of Life Instrument with eight items. In this study, direct medical and non-medical costs and costs of productivity loss will be considered. To assess safety, laboratory and electrocardiography tests will be conducted during the screening and post-intervention visits. Results : The recruitment has been completed after first enrolling on 17 December 2021. Now Study is underway on several participants. The results of this clinical study will be presented at a congress(iSAMS 2023) and will be submitted for publication in relevant journals. Conclusion: Pharmacopuncture is expected to be effective and cost-effective for treating insomnia disorder due to the combined effects of acupuncture and herbal medicine. The additional benefits of pharmacopuncture over acupuncture in insomnia treatment can promote further clinical research of various types and methods of pharmacopuncture. The clinical evidence of this pragmatic RCT regarding pharmacopuncture for insomnia is expected to facilitate clinical decision-making and healthcare policy-making.