Title

Clinical Trial of Sipjeondaebo-tang on Fatigue of Breast Cancer Patients
Sipjeondaebo-tang for Alleviating Fatigue Measured by Brief Fatigue Inventory and EORTC-QLQ-C30, BR23 Score Change Among Patients With Breast Carcinoma Receiving Chemotherapy
  • Phase

    N/A
  • Study Type

    Interventional
  • Status

    Unknown status
  • Intervention/Treatment

    deciten ...
  • Study Participants

    48
This is a pilot study that investigate efficacy and safety of Sipjeondaebo-tang on fatigue of patients with breast carcinoma receiving chemotherapy.
Study Started
Mar 20
2017
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Jun 30
2018
Anticipated
Last Update
Sep 15
2017

Drug Sipjeondaebo-tang

Herbal medicine which is a compound of 10 herbs.

  • Other names: Deciten granule

A group Experimental

Take Sipjeondaebo-tang on 0~2 week, 3~5 week of clinical trial period, total of 4 weeks

B group Experimental

Take Sipjeondaebo-tang on 6~8 week, 9~11 week of clinical trial period, total of 4 weeks

Criteria

Inclusion Criteria:

men and women aged over 18 years
patients who have histologically or cytologically confirmed breast tumor
patients who applicable AC(doxorubicin + cyclophosphamide)
ECOG score 0 to 2

Exclusion Criteria:

patient impossible to orally intake
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
No Results Posted