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Evaluation of the effect of Zishui Qinggan Decoction on vasomotor symptoms after endocrine therapy for breast cancer: a randomized, double-blind, placebo-controlled, multicenter clinical study

Evaluation of the effect of Zishui Qinggan Decoction on vasomotor symptoms after endocrine therapy for breast cancer: a randomized, double-blind, placebo-controlled, multicenter clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084530
Enrollment
Unknown
Registered
2024-05-20
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Vasomotor symptoms after endocrine therapy for breast cancer

Interventions

Treatment group :Zishui Qinggan Yin granules

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) It meets the VMS diagnostic criteria of western medicine for breast cancer after endocrine therapy. (2) Meets the traditional Chinese medicine syndrome criteria for kidney deficiency and liver depression. (3) Has received endocrine therapy for more than 3 months (such as tamoxifen, toremifen, goserelin, leuprorelin, etc.) and is currently undergoing regular endocrine therapy. (4) The frequency of VMS attacks exceeding 21 times per week. (5) Women over 18 years old who have not menopaused. (6) Expected survival time = 6 months and KPS score = 70 points. (7) Patients voluntarily participate in this study, can be followed up, and sign an informed consent form for treatment before enrollment.

Exclusion criteria

Exclusion criteria: (1) Tumor recurrence or metastasis has occurred. (2) Patients who cannot adhere to endocrine drug treatment during the trial period. (3) Postmenopausal women or those with a history of severe organic lesions in the uterus and ovaries or a history of surgery, or those who have already experienced menopausal VMS before endocrine therapy. (4) The relevant medical records of breast cancer are incomplete. (5) Patients who have used other drugs or treatments to intervene in ovarian function at least 4 weeks prior to the start of the study. (6) Individuals who are allergic to the drugs used in this study or unable to take traditional Chinese medicine treatment normally. (7) Participants in clinical trials of other drugs. (8) Individuals with severe cardiovascular and cerebrovascular diseases, mental illnesses, or severe impairment of liver and kidney function

Design outcomes

Primary

MeasureTime frame
Severity score of VMS ;

Secondary

MeasureTime frame
Improved Kupperman rating;Traditional Chinese Medicine Syndrome Scoring;

Countries

China

Contacts

Public ContactMa Jing

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion

majing2609@163.com+86 158 2221 7437

Outcome results

None listed

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