Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Not Applicable

Completed

• Conditions: Fatigue

• Registration Number: NCT04319692
• Lead Sponsor: Pusan National University Yangsan Hospital

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;

Study Timeline

• Study Start: 2020-03-19
• Study First Submitted: 2020-03-21
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue severity scale	8 weeks	Fatigue severity scale, minimum\~maximum values (1\~7), higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Creatinine kinase level	8 weeks	Creatinine kinase level (IU/L)
Lactate level	8 weeks	Lactate level (mg/dL)
Urinary malondialdehyde level	8 weeks	Urinary malondialdehyde level (mmol/mg Cr)

Trial Locations

Locations (1)

Pusan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeungsangnam-do, Korea, Republic of