Effect of GJD on Stress Hormones and Oxidative Stress-related Biomarkers under Lack of Sleep

• Register: KCT
• Last refreshed on: 11 March 2019
• Main ID: KCT0001681
• Date of registration: 2015-10-29
• Prospective Registration: No
• Primary sponsor: Daejeon Korean Medicine Hospital of Daejeon University
• Public title: Effect of GJD on Stress Hormones and Oxidative Stress-related Biomarkers under Lack of Sleep
• Scientific title: Effect of GJD on Stress Hormones and Oxidative Stress-related Biomarkers under Lack of Sleep : a Randomized, Double-Blinded, Placebo controlled, Crossover Clinical Trial
• Date of first enrolment: 2015-09-07
• Target sample size: 24
• Recruitment status: Completed
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=6683
• Study type: Interventional Study
• Study design: Primary Purpose : Treatment, Intervention Model : Cross-over, Blinding/Masking : Double, Blinding Target : Subject, Investigator, Outcome Accessor, Allocation : RCT
• Phase: Not applicable

Countries of recruitment

Korea, Republic of

Contacts

• Name: Chang Gue Son
• Affiliation: Daejeon University

• Name: Chang Gue Son
• Affiliation: Daejeon University

Key inclusion & exclusion criteria

Inclusion criteria: (1) Healthy male volunteers aged 19 to 45 years at the screening visit
(2) The participant must be over 45 kg, with a body mass index of 18.5–30 kg/m2 at the screening visit.
(3) The participant must not have any congenital defects or chronic diseases that have been present within the 3 years prior to the screening visit, nor should he present any pathological or abnormal clinical findings on physical examination.
(4) The participant must not have any sleeping disorders, and must have a Pittsburgh sleep quality index (Korean version; PSQI-K) score of 5 points or lower.
(5) The participant must have kept normal nocturnal sleeping hours (between 21:00 and 09:00) for a week before the first administration of the investigational drug (or placebo).
(6) The participant must have slept daily on average at least 7 hours a night for a week before the first administration of the investigational drug (or placebo).
(7) The participant must be a non-smoker, or an ex-smoker who stopped at least one year before the screening visit.
(8) The participant must comprehend the purpose and process of the study, as well as the properties of the investigational drug, and voluntarily sign the written informed consent form that has been approved by the Institutional Review Board (IRB) of Daejeon University Korean Medicine Hospital.
Exclusion criteria: (1) A clinically significant medical history, or a current disease, in one of the following areas: cardiovascular, respiratory, gastrointestinal, hepatic, metabolic and endocrine, renal and urinary, reproductive, musculoskeletal, skin and connective tissue, neurological, psychiatric, or allergy (other than seasonal allergies that are asymptomatic at the screening visit)
(2) A medical history of gastrointestinal diseases (esophageal achalasia, esophageal stricture, or Crohn’s disease) or operations (other than simple appendectomy or hernia surgery) that may affect drug absorption
(3) Lab test results showing the following values: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than twice the upper limit of the normal range
(4) History of alcohol or drug abuse within the 12 months before the screening visit
(5) History of regular alcohol consumption (> 210 g/week) within the 6 months before the screening visit. (Beer [5% v/v]: 250 mL = 10 g, soju (20% v/v): 50 mL = 8 g, wine (12% v/v): 125 mL = 12 g)
(6) Subjects who participated in another clinical study during the 2 months before the screening visit
(7) Prescription of drugs with known effects on drug-metabolizing enzymes (e.g. dexamethasone, phenytoin, carbamazepine, rifabutin, rifampicin, phenobarbital, ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nelfinavir, ritonavir, clarithromycin, telithromycin, voriconazole etc.) during the 30 days before the screening visit
(8) Whole blood donation during the 2 months before the screening visit, or specific blood components donation in the month before the screening visit
(9) Seated systolic blood pressure = 140 mmHg, or diastolic blood pressure of = 90 mmHg at the screening visit
(10) Intake of prescribed or over-the-counter drugs during the 7 days before the first administration of the investigational drug (or placebo)
(11) Consumption of alcohol during the 7 days before the first administration of the investigational drug (or placebo)
(12) Serious, acute, or chronic medical or mental conditions, or abnormal lab findings that could be exacerbated by administration of the investigational drug or participation in the study, or could affect the study outcomes
(13) Hypersensitivity to the investigational drug or any of its components
(14) Absence of intention or ability to adhere to the behavioral rules and requirements as specified in the present protocol
(15) Any person considered unsuitable for participation in the study by the principal investigator

Age minimum: 19(Year)
Age maximum: 45(Year)
Gender: Male

Health Condition(s) or Problem(s) studied

Symptoms, signs and abnormal clinical and laboratory findings, NEC

Intervention(s)

Drug : Randomized, double-blind, single-dose, cross-over clinical trial
Group A: Oral administration of GJD during phase I, oral administration of placebo during phase II
Group B: Oral administration of placebo during phase I, oral administration of GJD during phase II
In both phases, participants will be administered GJD or the placebo twice a day for 3 days.

Primary Outcome(s)

Serum cortisol

Secondary Outcome(s)

Fatigue Severity Scale-Korean version

glutathione [GSH] and glutathione reductase [GSH-Rx]

Epinephrine

interleukin-2(IL-2)

T-cell

B-cell

brief fatigue inventory-Korean version(BFI-K)

Catalase

malondialdehyde [MDA]

P.carbonyl

total antioxidant capacity [TAC]

Leeds sleep evaluation questionnaire-Korean version(KMLESQ)

reactive oxygen species [ROS]

heart rate variability

homocysteine

nitric oxide [NO]

Norepinephrine

salivary cortisol

tumor necrosis factor-a(TNF-a)

interferon-?(IFN-?)

interleukin-12(IL-12)

interleukin-10(IL-10)

natural killer cells[NK-cell]

superoxide dismutase [SOD]

Source(s) of Monetary Support

Korea Institute of Oriental Medicine

Ethics review

Status: Submitted approval
Approval date:
Contact:

Institutional Review Board of Daejeon University hospital of oriental medicine

[phone]

Results

• Date Posted: 29/10/2015