Last updated: February 24, 2023
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05548374
2022-007-KY
Ages 18-55 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Meeting the diagnosis criteria of cyclic breast pain.
- Female patients aged between 18 and 55.
- Relatively regular menstrual cycle.
- Cyclic breast pain lasting for 3 consecutive menstrual cycles or more.
- The score of worst pain ≥5 on Numerical Rating Scale and any level of breast painlasting 5-21 days during the run-in period of one menstrual cycle.
- No previous experience of acupuncture for breast diseases.
- Willing to use nonhormonal contraceptives if any risk of pregnancy.
- Volunteer to the trial and signing written informed consent.
Exclusion
Exclusion Criteria:
- Noncyclic breast pain.
- Extramammary pain only.
- A history of breast cancer or suspicious of malignancy breast disease by examinations.
- The Breast Imaging Reporting and Data System (BI-RADS) category 4-6 in ultrasound ormammography examinations.
- Combined with mastitis.
- Breast pain following injury, surgery, hormones, and/or other drugs.
- Usage of hormones (including hormonal contraceptives) in the past three months.
- Combined with severe diseases in the cardiac, respiratory, renal, liver, andhematopoietic systems, psychiatric disorder and/or cognitive disorders.
- A history of bilateral ovariectomy or premature ovarian failure.
- Pregnancy, lactation, or wishing to conceive before the end of the trial.
- Poor adherence.
Study Design
Total Participants: 60
Study Start date:
March 01, 2023
Estimated Completion Date:
September 30, 2024
Connect with a study center
Yuanjie Sun
Beijing, Beijing 100053
ChinaActive - Recruiting
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