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A Randomized, Double-Blind, Controlled, Prospective Pilot Clinical Trial of Rushu Xitong Oil for Mammary Hyperplasia with Mastalgia

A Randomized, Double-Blind, Controlled, Prospective Pilot Clinical Trial of Rushu Xitong Oil for Mammary Hyperplasia with Mastalgia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001214
Enrollment
Unknown
Registered
2026-05-14
Start date
2026-05-18
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

mammary gland hyperplasia with breast pain

Interventions

Treatment group 1:Drug intervention 1
Treatment group 2:Drug intervention 2
Control group:Placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for mammary hyperplasia; 2. Have a history of cyclic premenstrual breast pain with a VAS pain score = 4 points; 3. Female aged 18–65 years (inclusive); 4. Have not used hormonal preparations, oral contraceptives, or hormone replacement therapy within the past 6 months; 5. Have normal, unbroken skin on the breasts; 6. Voluntarily agree to participate in the clinical trial and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with mastitis, malignant breast tumors, or other breast diseases requiring surgical intervention; 2. Patients who have previously undergone breast plastic surgery or breast surgery within the past 3 months; 3. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems; or peptic ulcer disease; or severe life-threatening illnesses (e.g., malignancy, acquired immunodeficiency syndrome [AIDS]); or patients with mental or legal disabilities; 4. Anterior or lateral chest pain caused by other diseases; 5. Pregnant or lactating women, or women planning pregnancy within the next 3 months; 6. Patients with allergic diathesis or known hypersensitivity to any components of the study medication; 7. Patients with other conditions that, in the investigator's opinion, may reduce the likelihood of enrollment or complicate participation, such as circumstances prone to loss to follow-up (e.g., unstable work environment), or those unable to provide adequate informed consent due to mental and behavioral disorders; 8. Patients who have participated in another clinical trial within the past month.

Design outcomes

Primary

MeasureTime frame
Short-form McGill Pain Questionnaire(SF-MPQ);

Secondary

MeasureTime frame
Short-form McGill Pain Questionnaire(SF-MPQ);

Countries

China

Contacts

Public ContactQianjun Chen

Guangdong Provincial Hospital of Chinese Medicine

cqj55@163.com18688883505

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026