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The kidney tonifying depression relieving and anti-cancer formula regulates the endocrine treatment of breast cancer patients in the early stage A randomized controlled study of anxiety

The kidney tonifying depression relieving and anti-cancer formula regulates the endocrine treatment of breast cancer patients in the early stage A randomized controlled study of anxiety

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001721
Enrollment
Unknown
Registered
2025-09-15
Start date
2025-04-29
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Breast Cancer

Interventions

Experimental group:The Kidney-Tonic and Depression-Relieving Anti-Cancer Formula (Proactive Anti-Cancer Foundation Formula: Codonopsis, Ophiopogon, Schisandra, Poria, Hedyotis, whole scorpion, raw dra
Control group:The Foundation Formula for Tonic and Anti-Cancer (Paeoniae Radix, Ophiopogon japonicus, Schisandra Chinensis, Poria cocos, Hedyotis diffusa, Scorpion, Dragon Bone and Turtle Shell, Honey

Sponsors

Beijing Shijitan Hospital Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Selection criteria: (1) The patient meets the breast cancer related diagnostic criteria in the Guidelines and Norms for Breast Cancer Diagnosis and Treatment of Chinese Anti-Cancer Association (2024 edition) and has undergone surgery. The TCM syndrome is identified as liver depression and kidney deficiency syndrome (the syndrome is formulated according to the Guiding Principles for Clinical Research of New Traditional Chinese Medicine). (2) Age over 18 years old and receiving endocrine therapy within 3 months. (3) Hamilton Anxiety Scale (HAMA) score of = 7. (4) Anxiety self-rating scale (SAS) score> or = 50. (5) Survive for more than 6 months and cooperate with the investigator to complete the study. (6) Good compliance informed consent must be signed before enrollment.

Exclusion criteria

Exclusion criteria: Exclusion criteria: (1) A history of mental illness or (and) anxiety disorder. (2) Allergy to the study drug. (3) Combined cognitive or auditory and visual dysfunction. (4) Patients with severe cardiovascular and cerebrovascular diseases liver kidney hematopoietic system or other malignant tumors. (5) A history of anti-anxiety or other psychiatric drug treatment within 1 month.

Design outcomes

Primary

MeasureTime frame
TCM syndrome points;Hamilton Anxiety Rating Scale (HAMA) scores;Anxiety Self-Rating Scale (SAS) score;Breast Cancer Patient Life Quality Measurement Scale (FACT-B) score;

Secondary

MeasureTime frame
Levels of tumor markers (CA153, CEA, CA125);estrogen level ;Records of adverse reactions;Completion of treatment;Safety indicators;

Countries

China

Contacts

Public ContactPan Guofeng

Beijing Shijitan Hospital Capital Medical University

pan.gf1218@163.com13522147258

Outcome results

None listed

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