Status:
COMPLETED
Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue
Lead Sponsor:
Pusan National University Yangsan Hospital
Conditions:
Fatigue
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Fermented Prunus Mume Vinega on Improvement of Fatigue in adults for 8 weeks.
Detailed Description
Previous studies have indicated that Fermented Prunus Mume Vinega may have the ability to improve fatigue. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to ...
Eligibility Criteria
Inclusion
- Those who complain of fatigue for more than 1 month
- Fatigue Severity Scale 3 points or more
Exclusion
- chronic hepatitis B or C infection
- being treated for hypothyroidism or hyperthyroidism
- more than twice the normal upper limit of Creatinine
- Liver enzyme value is more than twice the normal upper limit
- Uncontrolled diabetes (over 160 mg / dl of fasting blood sugar)
- Uncontrolled hypertension (more than 160/100 mmHg, measured after 10 minutes of stability in subjects) or those with heart disease, such as angina or myocardial infarction
- taking medications that affect fatigue within the past 1 month (psychiatric drugs such as Chinese medicine, soy drugs, depression, beta-blockers, steroids, hormones, etc.). However, intermittent medication due to sleep disorders is excluded.
- a history of gastrointestinal resection or complain of severe gastrointestinal symptoms such as heartburn and indigestion
- already have participated in or plan to participate in another drug clinical trial
- Alcohol abusers
- pregnant, lactating or have a pregnancy plan during the clinical trial period
- allergic reactions to Fermented Prunus Mume Vinegar
- A person deemed inappropriate by the researcher for other reasons
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04319692
Start Date
March 19 2020
End Date
December 31 2020
Last Update
April 28 2021
Active Locations (1)
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1
Pusan National University Yangsan Hospital
Yangsan, Gyeungsangnam-do, South Korea, 50612