Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04319692
• Other study ID #: 02-2018-030
• Status: Completed
• Phase: N/A
• Start date: March 19, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Pusan National University Yangsan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue

Intervention

Dietary Supplement:
• Fermented Prunus Mume Vinegar group
This group takes Fermented Prunus Mume Vinegar for 8 weeks
• Placebo group
This group takes placebo for 8 weeks.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Gyeungsangnam-do

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue severity scale	Fatigue severity scale, minimum~maximum values (1~7), higher scores mean a worse outcome.	8 weeks
Secondary	Lactate level	Lactate level (mg/dL)	8 weeks
Secondary	Creatinine kinase level	Creatinine kinase level (IU/L)	8 weeks
Secondary	Urinary malondialdehyde level	Urinary malondialdehyde level (mmol/mg Cr)	8 weeks