Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
NCT ID: NCT02858856
Last Updated: 2017-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
48 participants
INTERVENTIONAL
2017-03-20
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
NONE
Study Groups
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A group
Take Sipjeondaebo-tang on 0\~2 week, 3\~5 week of clinical trial period, total of 4 weeks
Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
B group
Take Sipjeondaebo-tang on 6\~8 week, 9\~11 week of clinical trial period, total of 4 weeks
Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
Interventions
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Sipjeondaebo-tang
Herbal medicine which is a compound of 10 herbs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who have histologically or cytologically confirmed breast tumor
* patients who applicable AC(doxorubicin + cyclophosphamide)
* ECOG score 0 to 2
Exclusion Criteria
* patient with dementia, delirium and depression
* patient suffering from diseases like chronic hepatitis B, C or hepatocirrhosis
* severe liver disability (3-fold the normal high range value for ALT, AST)
* patient who has diabetes not controlled by diet, hypertension, hyperthyroidism,
* severe systemic disease
* use of other investigational products within the past 30 days
* hypersensitivity to investigational product
* others who are judged not to be appropriate to study
18 Years
ALL
No
Sponsors
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Catholic Kwandong University
OTHER
Kyunghee University Medical Center
OTHER
Responsible Party
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Seong-Gyu Ko
Prof.
Locations
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International St. Mary's Hospital
Incheon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Sipjeondaebo-tang in patients with breast cancer with fatigue: a protocol for a pilot, randomised, double-blind, placebo-controlled, cross-over trial. BMJ Open. 2018 Jul 6;8(7):e021242. doi: 10.1136/bmjopen-2017-021242.
Other Identifiers
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ISEE_2016_SJDBT
Identifier Type: -
Identifier Source: org_study_id