Efficacy and Safety of Sipjeondaebo-Tang (Shi-Quan-Da-Bu-Tang) for Chronic Fatigue Syndrome: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Background. Sipjeondaebo-tang (SDT), also known as Shi-Quan-Da-Bu-Tang, is a treatment for both qi and blood deficiency syndromes in traditional Korean medicine. It is also used to treat chronic fatigue syndrome (CFS) in Korea. Herein, we present the protocol for a study to assess the efficacy and safety of SDT for treating CFS. Methods. This will be a multicenter, randomized, double-blind, controlled trial with two parallel-treatment arms: an SDT group and a placebo group. Ninety-six patients with CFS aged between 19 and 65 years will be recruited from two hospitals in Korea. Participants will be randomly allocated at a ratio of 1: 1 between the two groups. Participants will receive 3 g doses of SDT or placebo thrice daily for 8 weeks. Follow-up evaluations will be performed for 4-6 weeks after the drug administration period. The primary outcome will be the rating of participants' fatigue symptoms using the Checklist Individual Strength questionnaire. Outcomes will be assessed at baseline, week 4, and week 8, as well as during follow-up. An efficacy evaluation and safety assessment will be performed. This study will be based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 statement. This protocol and informed consent guidelines were reviewed and approved by the institutional review board of Kyung Hee University Korean Medicine Hospital at Gangdong in the Republic of Korea (KHNMCOH 2017-06-004-001). The protocol was registered with the Clinical Research Information Service. Written informed consent will be obtained from all study participants prior to enrollment in the study. Results will be published in a peer-reviewed journal and presented at a scientific conference. Discussion. This study is expected to provide novel, accurate information regarding the 38 efficacy and safety of SDT for CFS in adults. Trial Registration. This trial is registered with https://cris.nih.go.kr; CRIS identifier (KCT0002684) registered on February 9, 2018.