Clinical trial NCT04319692: Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue
Official title: Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 investigate the effects of tFermented Prunus Mume Vinega on Improvement of Fatigue in adults; the safety of the compound are also evaluate. The Investigators examine fatigue severity scale, lactate, creatinine kinase, urinary malondialdehyde at baseline, as well as after 4 and 8 weeks of intervention. Sixty adults were administered either 600 mg of Fermented Prunus Mume Vinega or a placebo each day for 8 weeks;

Eligibility criteria: Inclusion Criteria:

* Those who complain of fatigue for more than 1 month
* Fatigue Severity Scale 3 points or more

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fatigue severity scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Lactate level
timeFrame: 8 weeks
measure: Creatinine kinase level
timeFrame: 8 weeks
measure: Urinary malondialdehyde level
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References: