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Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319692
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Sang Yeoup Lee, 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.

Condition or disease Intervention/treatment Phase
Fatigue Dietary Supplement: Fermented Prunus Mume Vinegar group Dietary Supplement: Placebo group Not Applicable

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;

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Fermented Prunus Mume Vinegar group
This group takes Fermented Prunus Mume Vinegar for 8 weeks.
Dietary Supplement: Fermented Prunus Mume Vinegar group
This group takes Fermented Prunus Mume Vinegar for 8 weeks

Placebo Comparator: Placebo group
This group takes placebo for 8 weeks.
Dietary Supplement: Placebo group
This group takes placebo for 8 weeks.




Primary Outcome Measures :
  1. Fatigue severity scale [ Time Frame: 8 weeks ]
    Fatigue severity scale, minimum~maximum values (1~7), higher scores mean a worse outcome.


Secondary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319692


Contacts
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Contact: Sang Yeoup Lee 360-2860 ext 055 saylee@pnu.edu
Contact: Ye Li Lee 360-2860 ext 055 yeri1230@gmail.com

Locations
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Korea, Republic of
Pusan National University Yangsan Hospital Recruiting
Yangsan, Gyeungsangnam-do, Korea, Republic of, 50612
Contact: Sang-Yeoup Lee, Pf.    82-55-360-2860    saylee@pnu.edu   
Sponsors and Collaborators
Pusan National University Yangsan Hospital
Investigators
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Principal Investigator: Sang Yeoup Lee Pusan National University Yangsan Hospital
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Responsible Party: Sang Yeoup Lee, Professor, Pusan National University Yangsan Hospital
ClinicalTrials.gov Identifier: NCT04319692    
Other Study ID Numbers: 02-2018-030
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms
Acetic Acid
Anti-Bacterial Agents
Anti-Infective Agents