Clinical Efficacy and Safety of "Baihe Dihuang Yangxin Ointment" in Treating Chronic Fatigue Syndrome: A Single-Center Randomized Controlled Trial

INTERVENTION: Experimental Group:Routine Lifestyle Intervention: (1) Health Guidance: Smoking cessation and alcohol limitation; maintaining a positive and optimistic mindset; avoiding emotional fluctuations and excessive mental stress. Health education will be conducted by the study physician at each visit, and a Healthy Lifestyle Guidance Manual will be distributed. (2) Dietary Regulation: Increased consumption of fresh vegetables, fruits, legumes, and whole grains; reduced intake of red meat; maintenance of a low‐salt, low‐cholesterol diet; avoidance of overeating or strict dieting. (3) Moderate Exercise: Participants will be encouraged to engage in low‐to‐moderate intensity aerobic exercise (e.g., walking, jogging, swimming, Tai Chi) for 30–60 minutes per session, 3–5 times weekly, with adjustments based on individual physical capacity to avoid overexertion. (4) Regular Rest: 7–8 hours of sleep daily is recommended; establishing a consistent sleep routine; avoiding staying up late; reducing electronic screen use before bedtime. Implementation of Routine Lifestyle Intervention: At the screening visit, the study physician will provide participants with the Healthy Lifestyle Guidance Manual and conduct face‐to‐face health education (approximately 15 minutes). Adherence to the lifestyle regimen will be assessed via phone or WeChat at each follow‐up, with reinforcement counseling as needed. On the basis of routine lifestyle intervention, participants will receive oral Baihe Dihuang Yangxin Ointment (Lily Bulb and Rehmannia Heart‐Nourishing Ointment). The ointment is to be torn open and taken with warm water or consumed directly. One sachet twice daily for 8 consecutive weeks.;Control Group:Routine Lifestyle Intervention(1) Health Guidance: Smoking cessation and alcohol limitation; main CONDITION: Chronic Fatigue Syndrome (CFS) PRIMARY OUTCOME: Multidimensional Fatigue Inventory; SECONDARY OUTCOME: Pittsburgh Sleep Quality Inde X(PSQI);Hospital Anxiety and Depression Scale;Short Form Health Survey;Serum inflammatory factors;HPA axis hormones; INCLUSION CRITERIA: (1) Meet Western medicine and/or TCM diagnostic criteria for CFS; (2) Age 18‐60 years; (3) No CFS‐related treatment in past month; (4) Voluntary participation with signed informed consent.