JPRN-jRCT1041190019
Suspended
Phase 2
A phase II randomized clinical trial to determine the effectiveness of goreisan and saireito for lower limb lymphedema in women treated for gynecologic cancer
Kajiyama Hiroaki0 sites40 target enrollmentApril 18, 2019
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- ower Limb Lymphedema
- Sponsor
- Kajiyama Hiroaki
- Enrollment
- 40
- Status
- Suspended
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Patients who underwent uterine malignancy surgery including retroperitoneal lymph node dissection or surgical operation of the uterine appendix malignant tumor by preoperative diagnosis of gynecological malignancy
- •2\) Patients diagnosed with secondary lymphedema in 1\)
- •3\) Patients with ECOG\-PS 0 or 1
- •4\) Patients whose main organ functions are adequately maintained
- •(A) White blood cell count 3,500 / mm 3 12 000 / mm 3
- •(B) Number of neutrophils 1,500 / mm 3
- •(C) Number of platelets 100,000 / mm 3
- •(D) Hb 9\.0 g / dL
- •(E) AST,ALT 100 IU / L
- •(F) Creatinine 1\.2 mg / dL
Exclusion Criteria
- •1\) Patients who are allergic to the ingredients of traditional Chinese medicine or goriso\-san/saireito
- •2\) Patients with severe complications (heart failure, renal failure, liver failure, hypoactive nutrition etc.) and severe mental illness
- •3\) Patients whose oral ingestion is impossible
- •4\) Patients diagnosed with primary lymphedema
- •5\) Patients with lower extremity vein thrombosis
- •6\) In addition, patients judged unsuitable for doctors to safely carry out this study
Outcomes
Primary Outcomes
Not specified
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