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Guben Yiqi Granules Intervention in Breast Cancer Patients with Liver Depression and Spleen Deficiency Syndrome During Endocrine Therapy: An RCT Clinical Study

Guben Yiqi Granules Intervention in Breast Cancer Patients with Liver Depression and Spleen Deficiency Syndrome During Endocrine Therapy: An RCT Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002301
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Breast cancer

Interventions

Treatment group:Guben Yiqi Granules Plus Endocrine Therapy
Control Group:Placebo + Endocrine Therapy

Sponsors

Gansu University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients diagnosed with breast cancer confirmed by pathology or cytodiagnosis. (2) Patients who have completed surgery or conventional treatments such as radiotherapy and chemotherapy, and have been on endocrine therapy for more than six months. (3) Patients diagnosed with Liver Qi Stagnation and Spleen Deficiency syndrome according to traditional Chinese medicine (TCM) criteria. (4) Patients experiencing adverse reactions such as sleep disorders, hot flashes, night sweats, and fatigue during endocrine therapy. (5) Patients aged between 18 and 85 years who can accurately report their symptoms. (6) Patients who have not received other Chinese herbal medications during endocrine therapy. (7) Patients who have signed the informed consent form, voluntarily participate in the clinical study, and are willing to undergo follow-up.

Exclusion criteria

Exclusion criteria: (1) Patients with mental disorders and cognitive impairments. (2) Patients with a KPS score <60 and an expected survival period of less than 12 months. (3) Patients with allergic constitutions. (4) Patients with severe heart, liver, or kidney dysfunction or other systemic diseases. (5) Patients who cannot adhere to endocrine therapy during treatment.

Design outcomes

Secondary

MeasureTime frame
"Fatigue Severity Scale";Hot Flushes Rating Scale;The improvement status of Traditional Chinese Medicine (TCM) syndromes.;Traditional Chinese Medicine Symptoms and Signs Scoring Scale;KPS Score;

Primary

MeasureTime frame
Sleep Monitoring;

Countries

China

Contacts

Public ContactZhang Yin Fang, Dou Yuan Yuan

Gansu University of Traditional Chinese Medicine Affiliated Hospital

zyfang1129@163.com17352103715

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026