Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Pusan National University Yangsan Hospital

Status: Completed

Conditions: Fatigue

Treatments: Dietary Supplement: Placebo group; Dietary Supplement: Fermented Prunus Mume Vinegar group

Study type: Interventional

Funder types: Other

Identifiers

NCT04319692

02-2018-030

Details and patient eligibility

About

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.

Full 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;

Enrollment: 80 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Fermented Prunus Mume Vinegar group

Experimental group

Description:

This group takes Fermented Prunus Mume Vinegar for 8 weeks.

Treatment:

Dietary Supplement: Fermented Prunus Mume Vinegar group

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 8 weeks.

Treatment:

Dietary Supplement: Placebo group