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Clinical validation of Shen Gua Formula for the treatment of upper limb lymphedema in post-mastectomy breast cancer patients.

Clinical validation of Shen Gua Formula for the treatment of upper limb lymphedema in post-mastectomy breast cancer patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002282
Enrollment
Unknown
Registered
2025-11-21
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Upper limb lymphadenopathy

Interventions

Observation group:Under lifestyle guidance, the patient received treatment with the Shen Gu Formula. The Shen Gu Formula was manufactured by the pharmaceutical factory as Chinese herbal granules, take
Placebo group:On the basis of lifestyle guidance, patients received treatment with Shen Gu Formula at a one-tenth dose, formulated into traditional Chinese medicine granules, twice daily, one packet e
Control Group:Under lifestyle guidance, the patient received spironolactone 20 mg orally once daily for a 28-day course.

Sponsors

Shanghai Fourth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Meets the diagnostic criteria for postmastectomy upper limb lymphedema; 2) Meets the diagnostic criteria for Traditional Chinese Medicine (TCM) edema disease; 3) Age between 18-80 years old; 4) Provide informed consent, voluntarily participate in the study, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Individuals with severe primary diseases of the brain, liver, kidneys, and endocrine system; 2)Patients with liver or kidney dysfunction; 3)Patients with other malignant tumors or metastatic lesions of malignant tumors; 4)Pregnant or breastfeeding women; 5)Individuals with allergic constitutions or allergies to multiple medications; 6)Patients with mental abnormalities or unwilling to cooperate; 7)Individuals with upper limb swelling caused by non-surgical factors; 8)Patients currently participating in other clinical trials or receiving other interventions.

Design outcomes

Primary

MeasureTime frame
Severity of upper limb lymphedema;Efficacy Index;TCM Disease Condition Efficacy Scoring;

Secondary

MeasureTime frame
Quality of Life Improvement Rating;DASH Upper Extremity Function Score;Safety Index;

Countries

China

Contacts

Public ContactLiu Hui

Shanghai Fourth People's Hospital

15122850979@163.com15122850979

Outcome results

None listed

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