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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001199
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome (CFS)

Interventions

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) D
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) fo
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 Guidan
Control Group:Routine Lifestyle Intervention(1) Health Guidance: Smoking cessation and alcohol limitation
main

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: (1) Drug-induced fatigue; (2) Psychiatric history; (3) BMI>40; (4) Major organ diseases or malignancies; (5) Pregnancy or impending delivery; (6) Drug allergies; (7) Participation in other clinical trials. Exclusion if any one of the above criteria is met.

Design outcomes

Primary

MeasureTime frame
Multidimensional Fatigue Inventory;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index (PSQI);Hospital Anxiety and Depression Scale;Short Form Health Survey;Serum inflammatory factors;HPA axis hormones;

Countries

China

Contacts

Public ContactXu Min

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

yudi1212@163.com15381068877

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026