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Chinese Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized, Double-blind, Controlled Study

Chinese Herbal Medicines for Menopausal Symptoms in Breast Cancer Patients: A Randomized, Double-blind, Controlled Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023382
Enrollment
Unknown
Registered
2019-05-25
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-05-27

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

Conditions

Menopause, Breast cancer

Interventions

Sponsors

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? Patients with primary breast cancer (stage 0-III) by pathologic diagnosis and with menopausal symptoms; ? Aged 25-60 years; ? Patients are undergoing endocrine therapy for more than 3 months; ? The subjects experienced at least 4 times of moderate and severe hot flashes every day; ? The Karnofsky score is greater than or equal to 60 points; ? The predicted survival time is greater than or equal to 6 months; ? Voluntarily sign the informed consent file.

Exclusion criteria

Exclusion criteria: ? Patients with recurrent, metastatic breast cancer or other cancer diagnosed by imaging or histology; ? Patients who cannot adhere to endocrine therapy; ? Uncontrolled and/or diagnosed medical conditions such as severe liver, kidney, heart, and brain diseases; abnormal bone marrow function; Uncontrolled or untreated hypertension (SBP >160mmHg and/or DBP > 100mmHg), Uncontrolled or untreated diabetes; Or abnormal thyrotropin may lead to symptoms similar to menopausal symptoms. ? Pregnant and lactating women; ? Participated in phase I and II clinical trials in the past 6 months or participated in phase III and IV clinical trials in 3 months; ? Use other medications (e.g. tibolone, black cohosh extract or soy isoflavones, vitamins, etc.) for menopausal symptoms within 3 months; ? Allergic to the tested drug.

Design outcomes

Primary

MeasureTime frame
Greene Scale;

Secondary

MeasureTime frame
HFRDIS;QLQ-BR23;

Countries

China

Contacts

Public ContactJian Liu

he Second Affiliated Hospital of Guangzhou University of Chinese Medicine

jianliu@gzucm.edu.cn+86 15802034064

Outcome results

None listed

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