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Completed

NCT Number: NCT04319692

Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, Gyeungsangnam-do, 50612, South Korea

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fermented Prunus Mume Vinegar group

Dietary Supplement

This group takes Fermented Prunus Mume Vinegar for 8 weeks

Placebo Group

Dietary Supplement

This group takes placebo for 8 weeks.

Primary outcomes

  1. Fatigue severity scale

    Time frame: 8 weeks

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

Secondary outcomes

  1. Lactate level

    Time frame: 8 weeks

    Lactate level (mg/dL)

  2. Creatinine kinase level

    Time frame: 8 weeks

    Creatinine kinase level (IU/L)

  3. Urinary malondialdehyde level

    Time frame: 8 weeks

    Urinary malondialdehyde level (mmol/mg Cr)

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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