Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

N/ACompletedNCT04319692

Pusan National University Yangsan Hospital80 enrolled

Overview

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.

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;

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Fatigue

Interventions

Fermented Prunus Mume Vinegar groupDIETARY_SUPPLEMENT

This group takes Fermented Prunus Mume Vinegar for 8 weeks

Placebo groupDIETARY_SUPPLEMENT

This group takes placebo for 8 weeks.

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, South Korea

Outcomes

Primary Outcomes

Fatigue severity scale

Fatigue severity scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.

Time frame: 8 weeks

Secondary Outcomes

Lactate level

Lactate level (mg/dL)

Time frame: 8 weeks

Creatinine kinase level

Creatinine kinase level (IU/L)

Time frame: 8 weeks

Urinary malondialdehyde level

Urinary malondialdehyde level (mmol/mg Cr)

Time frame: 8 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.