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Trial Title:
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors
NCT ID:
NCT05717972
Condition:
Distress, Emotional
Sleep
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Kombucha
Description:
Kombucha is a fermented tea drink that originated in ancient Chinese civilization. It is
made by combining tea, juice, and SCOBY (Symbiotic Culture of Bacteria and Yeast).
During the fermentation process, the yeast in the SCOBY breaks down the sugar in the tea
releasing friendly probiotic bacteria, giving kombucha its fizzy body and its sweet and
tangy taste.
Arm group label:
A Group
Arm group label:
B Group
Summary:
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer
Survivors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Stage 0-III Breast Cancer
- No any cancer treatment in the following year
- Perceived emotional distress and poor sleep quality
- Agree to follow the protocol of this study
Exclusion Criteria:
- Stage IV Breast Cancer
- Pregnant women
- Abnormal liver, kidney, gastric, internal , immune, sleep disorder, metabolic,
psychic functions and need to take the prescription medications or medical
treatments regularly
- could not follow the protocol of this study
Gender:
All
Minimum age:
40 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Yang-Ming University
Address:
City:
Taipei
Zip:
11221
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
IChing Hou, PhD
Phone:
886-2-28267000
Phone ext:
7315
Email:
evita@ym.edu.tw
Investigator:
Last name:
IChing Hou, PhD
Email:
Principal Investigator
Start date:
December 12, 2022
Completion date:
December 12, 2025
Lead sponsor:
Agency:
National Yang Ming Chiao Tung University
Agency class:
Other
Source:
National Yang Ming Chiao Tung University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05717972