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A observational, prospective, multicenter real-world study on Shenqi shiyiwei Granules for the treatment of fatigue symptoms

A observational, prospective, multicenter real-world study on Shenqi shiyiwei Granules for the treatment of fatigue symptom

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000402
Enrollment
Unknown
Registered
2026-02-23
Start date
2026-04-23
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Fatigue symptoms

Interventions

Shenqi shiyiwei Granules Group:Oral Shenqi shiyiwei Granules

Sponsors

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old and above, gender unrestricted; 2. Total score of the Chinese version of the Piper Fatigue Revised Scale =4 points; 3. Patients with one or more chronic diseases, such as cancer, hypertension, diabetes, coronary artery disease, cerebrovascular disease, chronic obstructive pulmonary disease, chronic kidney disease, etc., and whose condition is assessed by the investigator to be in a stable phase (no acute exacerbation of the disease, no major complications, no significant changes in treatment plan, and symptoms/signs tend to stabilize in the past 3 months); 4. Voluntarily participating in this treatment plan, able to follow medical advice for regular follow-ups, and with good compliance.

Exclusion criteria

Exclusion criteria: 1. Individuals allergic to the investigational drug or its components; 2. Individuals with severe cardiovascular diseases, chronic liver disease (ALT or AST =1.5 times the upper limit of normal reference values), or kidney disease (serum creatinine > upper limit of normal reference values); 3. Pregnant or breastfeeding women; 4. Heavy drinkers and/or those with substance abuse or dependence; 5. Individuals who participated in other clinical trials of investigational drugs or medical devices within one month prior to signing the informed consent form and received treatment with the investigational drug or device; 6. Individuals deemed unsuitable for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Piper Fatigue Scale;

Secondary

MeasureTime frame
Health Survey Scale 36 (SF-36);6-minute walk test distance (if applicable);Inflammatory factors (if present, collect);

Countries

China

Contacts

Public ContactYang Guowang

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

guowang_yang@163.com19800339903

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026