Effects and Safety of Myelophil on Chronic Fatigue Syndrome

Not Applicable

Recruiting

• Conditions: Not Applicable

• Registration Number: KCT0002317
• Lead Sponsor: Daejeon Korean Medicine Hospital of Daejeon University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

1) Men and women aged 18 and over who are under 65
2) Those who meet the criteria for chronic fatigue syndrome according to the American Centers for Disease Control and Prevention (CDC) standards. In other words, a person who has passed six months since the beginning of severe fatigue that interferes with normal daily life without physical illness and subjective depression or anxiety that may cause fatigue
3) Four or more of the following 8 symptoms last for more than 6 months at the same time
? fatigue not resolved 24 hours after physical or mental activity
? Sleeping that does not refresh after morning weather
? Disability of short-term memory or concentration
? Muscle pain
? Joint pain without edema or erythema
? Headache of a different aspect
? Lymph node enlargement and tenderness of the neck or axilla
? Frequent repeated sore throat
4) Those who are mentally healthy and can understand and follow the required treatment normally
5) Those who voluntarily participate in this clinical trial and sign the agreement

Exclusion Criteria

1) Patients who need continuous medication such as cardiovascular disease, liver disease, kidney disease, etc.
2) Patients who have been treated for medical treatment before 6 months before, which may be a direct cause of chronic fatigue.
3) Laboratory findings include hemoglobin 12 g / dL (male) or less than 11 g / dL (female), liver function abnormality (AST or ALT more than twice the normal upper limit), kidney dysfunction (more than 20% of the normal upper limit of serum creatinine)factor.
4) Patients with high fat levels in ultrasonography.
5) Those with a history of malignant neoplasm.
6) Those who work at night.
7) Those who drink alchol more than twice a week.
8) Those with a body mass index of less than 16.5 or greater than 30
9) Those who have undergone organ transplantation or are currently receiving immunosuppressive drugs
10) Those who are taking drugs such as sleep inducing drugs due to sleep disorders
11) Those who used drugs, functional foods, and health supplements within the last 2 months to improve chronic fatigue.
12) Those who has been performing professional exercise therapy within the last 2 months to improve chronic fatigue.
13) Those who have been practicing professional counseling within the last 2 months to improve chronic fatigue
14) Pregnant women, lactating women or fertile women planning to conceive
15) When depression is thought to affect fatigue (Beck Depression Inventory > 25)
* Beck Depression Inventory
16) When anxiety affects fatigue (State-Trait Anxiety Inventory > 60)
* State-Trait Anxiety Inventory
17) When the doctor determines that there is a serious physical or mental defect that can not be understood and followed by the overall treatment

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in fatigue after taking medicine before test start

Secondary Outcome Measures

Name	Time	Method
The change in fatigue indicated by VAS after 12 weeks of taking myelofil;Changes in quality of life as measured by SF36 after 12 weeks of taking myelofil;Changes in indicators of serum reactive oxygen(serum ROS, MDA) and antioxidant index(TAC, catalase, SOD, total GSH, GSH-Px, GSH-Rd);Changes in blood cytokine levels(TNF-a : Tumor necrosis factor-alpha? IFN-? : Interferon-gamma)