Clinical efficacy of Jianqiao ancient moxibustion in treating chronic fatigue syndrome: a single-center randomized controlled superiority trial protocol.

Background: Chronic fatigue syndrome (CFS) is a widespread and debilitating disorder that profoundly impacts the physical and mental health of patients. In traditional Chinese medicine (TCM), spleen-kidney yang deficiency is recognized as the most prevalent syndrome associated with CFS. Moxibustion is commonly employed to mitigate fatigue and address yang deficiency; however, conventional moxa box moxibustion has demonstrated limited clinical efficacy in practice. Considering the intrinsic benefits of Jianqiao ancient moxibustion in terms of its herbal formula and treatment coverage, this randomized controlled superiority trial aims to compare the clinical efficacy of Jianqiao ancient moxibustion with that of moxa box moxibustion in patients with CFS who exhibit a spleen-kidney yang deficiency pattern. Methods: This single-center, single-blind randomized controlled superiority trial will enroll 90 eligible patients diagnosed with CFS exhibiting a spleen-kidney yang deficiency pattern. Participants will be randomly assigned in a 1:1 ratio to receive either Jianqiao ancient moxibustion or moxa box moxibustion, with each group receiving standardized interventions as outlined in the trial protocol. Each 60-min treatment session will be administered three times per week for 4 consecutive weeks. A follow-up assessment will be conducted at week 16. The primary outcome measure will be the Fatigue Scale-14. Secondary outcome measures will include the Spleen-Kidney Yang Deficiency Symptom Scale, the Self-Rating Anxiety Scale, the Self-Rating Depression Scale, and infrared thermal imaging. All evaluations will be performed at baseline, immediately post-intervention at week 4, and during follow-up at week 16. Discussion: It is hypothesized that Jianqiao ancient moxibustion will be more effective than moxa box moxibustion in alleviating symptoms in patients with CFS who have spleen-kidney yang deficiency. Furthermore, this study will employ infrared thermal imaging to assess alterations in the thermal characteristics of the Sanjiao and Governor Vessel both prior to and following moxibustion. This methodology may help elucidate the mechanisms underlying moxibustion's modulation of yang-qi distribution in patients with CFS. Study protocol registration: https://www.chictr.org.cn/showproj.html?proj=193045.