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Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Primary Purpose

Fatigue

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fermented Prunus Mume Vinegar group
Placebo group
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fermented Prunus Mume Vinegar group

Placebo group

Arm Description

This group takes Fermented Prunus Mume Vinegar for 8 weeks.

This group takes placebo for 8 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lactate level
Lactate level (mg/dL)
Creatinine kinase level
Creatinine kinase level (IU/L)
Urinary malondialdehyde level
Urinary malondialdehyde level (mmol/mg Cr)

Full Information

First Posted
March 21, 2020
Last Updated
April 27, 2021
Sponsor
Pusan National University Yangsan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04319692
Brief Title
Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue
Official Title
Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 19, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fermented Prunus Mume Vinegar group
Arm Type
Experimental
Arm Description
This group takes Fermented Prunus Mume Vinegar for 8 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This group takes placebo for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fermented Prunus Mume Vinegar group
Intervention Description
This group takes Fermented Prunus Mume Vinegar for 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo group
Intervention Description
This group takes placebo for 8 weeks.
Primary Outcome Measure Information:
Title
Fatigue severity scale
Description
Fatigue severity scale, minimum~maximum values (1~7), higher scores mean a worse outcome.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Lactate level
Description
Lactate level (mg/dL)
Time Frame
8 weeks
Title
Creatinine kinase level
Description
Creatinine kinase level (IU/L)
Time Frame
8 weeks
Title
Urinary malondialdehyde level
Description
Urinary malondialdehyde level (mmol/mg Cr)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Yeoup Lee
Organizational Affiliation
Pusan National University Yangsan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Gyeungsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

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Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

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