Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-19

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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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;

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Fermented Prunus Mume Vinegar group

This group takes Fermented Prunus Mume Vinegar for 8 weeks.

Group Type EXPERIMENTAL

Fermented Prunus Mume Vinegar group

Intervention Type DIETARY_SUPPLEMENT

This group takes Fermented Prunus Mume Vinegar for 8 weeks

Placebo group

This group takes placebo for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

This group takes placebo for 8 weeks.

Interventions

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Fermented Prunus Mume Vinegar group

This group takes Fermented Prunus Mume Vinegar for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo group

This group takes placebo for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes