Effect of Fermented Prunus Mume Vinegar on Improvement of Fatigue

Study Overview
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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.

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;

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

Conditions
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Fatigue

Intervention / Treatment
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* Dietary Supplement: Fermented Prunus Mume Vinegar group
* Dietary Supplement: Placebo group


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fermented Prunus Mume Vinegar group<br>This group takes Fermented Prunus Mume Vinegar for 8 weeks. | Dietary Supplement: Fermented Prunus Mume Vinegar group<br>* This group takes Fermented Prunus Mume Vinegar for 8 weeks<br>|
| Placebo Comparator: Placebo group<br>This group takes placebo for 8 weeks. | Dietary Supplement: Placebo group<br>* This group takes placebo for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue severity scale | Fatigue severity scale, minimum maximum values (1 7), higher scores mean a worse outcome. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate level | Lactate level (mg/dL) | 8 weeks | 
| Creatinine kinase level | Creatinine kinase level (IU/L) | 8 weeks | 
| Urinary malondialdehyde level | Urinary malondialdehyde level (mmol/mg Cr) | 8 weeks |