Fatigue
Conditions
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;
Interventions
DIETARY_SUPPLEMENTFermented Prunus Mume Vinegar group
This group takes Fermented Prunus Mume Vinegar for 8 weeks
DIETARY_SUPPLEMENTPlacebo group
This group takes placebo for 8 weeks.
Sponsors
Pusan National University Yangsan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue severity scale | 8 weeks | Fatigue severity scale, minimum\ maximum values (1\ 7), higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lactate level | 8 weeks | Lactate level (mg/dL) |
| Creatinine kinase level | 8 weeks | Creatinine kinase level (IU/L) |
| Urinary malondialdehyde level | 8 weeks | Urinary malondialdehyde level (mmol/mg Cr) |
Countries
South Korea
Outcome results
None listed