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Clinical study on the treatment of Mastalgia with XiaoPi Tincture

A prospective randomized controlled trial of Xiaoyu in the treatment of Mastalgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002343
Enrollment
Unknown
Registered
2019-05-18
Start date
2019-07-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Mastalgia

Interventions

Sponsors

Guangdong Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged between 20-55 years old; 2. Comply with the diagnostic criteria for mammary gland hyperplasia (Mastalgia); 3. The first diagnosis of breast pain or an untreated patient for at least 6 months; 4. The course of disease has been more than 3 months; 5. The degree of pain was visual analogue scale (VAS) I:5-8; 6. Patients willing to participate in the RCT and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1. Mastitis patients; 2. Suspected or confirmed breast cancer; 3. With breast fibroadenomas and other neoplastic diseases; 4. Pregnant or nearly 3 months with birth planning and lactating women; 5. Combined with serious primary diseases such as cardiovascular, cerebrovascular, hepatic, renal and hematopoietic systems, and mental patients; 6. Patients with irregular menstrual cyclessuch as polycystic ovary syndrome, adenomyosis and other patients.

Design outcomes

Secondary

MeasureTime frame
Blood routine,Stool, urine test, ALT, BUN, Cr;

Primary

MeasureTime frame
Pain score improvement rate before and after treatment;

Countries

China

Contacts

Public ContactXiaoyan Liu

Guangdong Provincial Hospital of TCM

yanlan_wu@yahoo.com.cn+86 13660796179

Outcome results

None listed

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